Email: [email protected]
Phone: +91 93135 43530
Address: 133/1 Ground, Mansuri Block, Opp. Dudheshwar Water Tank, Ahmedabad-380004, Gujarat, India
FDA Compliant Silicone O-Ring India — 21 CFR 177.2600 Certified VMQ — KELOR
FDA 21 CFR 177.2600 compliant silicone O-rings sourced from verified manufacturers — non-toxic · odourless · tasteless — repeated food contact safe — colour-coded red / translucent / white — VMQ temperature range -60°C to +230°C — DIN 3771 metric / AS568 inch / ISO 3601 — ID 1 mm to 500 mm — 50 Shore A standard — peroxide-cured and platinum-cured available — food processing · dairy · beverage · confectionery · bottling · kitchen equipment seals.
MOQ 1,000 Nos · MOV ₹50,000 · MTR with Every Batch · Custom to Drawing · GST Invoice (GSTIN: 24AKLPP6499B1ZT) · Pan India Dispatch · 2-Hour Quote
✅ What “FDA Compliant Silicone O-Ring” Actually Means
An FDA compliant silicone O-ring is one moulded from VMQ (silicone rubber) compound whose raw material formulation has been certified by the compound manufacturer to meet the extractables and compositional requirements of FDA 21 CFR 177.2600 — the US Code of Federal Regulations title that governs rubber articles intended for repeated contact with food. This is not a voluntary claim — it is a regulatory compliance declaration that carries legal liability. Every batch we supply comes with a Material Test Report (MTR) confirming FDA 21 CFR 177.2600 compliance.
- 📋 Regulation: FDA 21 CFR 177.2600 — Rubber Articles Intended for Repeated Use in Contact with Food
- 🧪 What it covers: Maximum permissible extractables when immersed in n-hexane and distilled water simulants — ensures no harmful substances migrate from the O-ring into food
- ✅ What it proves: The VMQ compound is non-toxic, odourless, tasteless, and will not contaminate food under repeated contact at service temperature
- 🚫 What it does NOT cover: Pharmaceutical drug contact (requires USP Class VI) · Medical implant contact (requires ISO 10993) · Drinking water contact (requires NSF/WRAS)
FDA Compliant Silicone O-Ring Product Images — KELOR Supply Range
FDA 21 CFR 177.2600 Compliant Silicone O-Rings — Red / Translucent — Food Contact Safe · Non-Toxic · Odourless
White FDA-Grade Silicone O-Rings — High Purity · Food Contact · Pharmaceutical Equipment · Clean Room Compatible
What Is FDA 21 CFR 177.2600 — and Why It Matters for Your Silicone O-Ring
FDA 21 CFR 177.2600 is the specific section of the United States Code of Federal Regulations that defines the compositional and extractables limits for rubber articles intended for repeated use in contact with food. It is the single most important regulation governing food-contact rubber seals worldwide — not just in the United States. India’s FSSAI (Food Safety and Standards Authority of India) references FDA food-contact material standards for imported food processing equipment, and most Indian food processing OEMs specify FDA 21 CFR 177.2600 compliance as a mandatory requirement on their purchase orders.
The regulation specifies two critical tests that the rubber compound must pass. First, the n-hexane extractables test — when a sample of the rubber is immersed in n-hexane (a fat-simulant solvent) for 7 hours at reflux temperature, the total extractables must not exceed 175 mg/dm². This ensures that fatty foods do not leach harmful substances out of the rubber. Second, the distilled water extractables test — when immersed in distilled water for 24 hours at reflux, total extractables must not exceed 20 mg/dm². This ensures that aqueous (water-based) foods remain uncontaminated.
A silicone O-ring that cannot demonstrate compliance with these extractables limits is not legally permitted for food contact in the United States, and is considered non-compliant by Indian food safety auditors who reference FDA standards. Using non-compliant O-rings in food processing equipment risks batch rejection, product recall, regulatory action, and legal liability for the food manufacturer.
🚨 Critical warning: Many Indian O-ring suppliers sell “food grade silicone O-rings” without providing any FDA compliance documentation. If your supplier cannot produce a compound manufacturer’s certificate confirming FDA 21 CFR 177.2600 extractables compliance, the O-rings are not FDA compliant — regardless of colour, appearance, or verbal assurance. “Red silicone” does not equal “FDA compliant.” Demand the MTR before installing any O-ring in food contact service. We provide MTR with every batch — no exceptions.
How to Verify Your Silicone O-Ring Is Genuinely FDA Compliant
Verifying FDA compliance is not about the colour of the O-ring or the supplier’s verbal assurance. It requires documented evidence at the compound level. Below is a practical checklist that food processing QA teams and procurement managers should use before approving any silicone O-ring for food contact installation.
1. Request the MTR
Ask your supplier for the Material Test Report confirming FDA 21 CFR 177.2600 compliance. If they cannot provide it, the O-ring is not FDA compliant — period.
2. Check Compound Certificate
The MTR must reference the VMQ compound manufacturer’s certification — not just the O-ring moulding shop’s claim. FDA compliance is a compound-level property.
3. Verify Extractables Data
The compound certificate should state n-hexane extractables ≤ 175 mg/dm² and distilled water extractables ≤ 20 mg/dm². If extractables data is missing, compliance is unverified.
4. Match Batch Numbers
Ensure the batch number on the MTR matches the batch number on the O-ring packaging. Mismatched or generic MTRs are a red flag.
5. Confirm the Regulation Number
The MTR must specifically cite “FDA 21 CFR 177.2600.” Generic claims like “food safe” or “food grade” without the CFR reference are legally meaningless.
6. Check Colour Coding
FDA-compliant VMQ is colour-coded for line identification. Red = standard FDA food grade. Translucent = high-purity FDA. White = FDA + USP Class VI pharma. No colour = no compliance claim.
ℹ️ KELOR guarantee: Every FDA compliant silicone O-ring batch we supply includes an MTR confirming: (1) VMQ compound manufacturer’s FDA 21 CFR 177.2600 certificate, (2) batch-specific extractables compliance, (3) hardness, tensile, elongation, and compression set data, (4) batch traceability number matching the packaging. No extra charge — included with every order.
FDA Compliant vs Non-FDA Silicone O-Ring — Why the Difference Costs (and Saves) Money
The price difference between FDA compliant and non-FDA silicone O-rings is typically 30-50% per piece. But the cost of installing a non-FDA O-ring in food contact service — if discovered during an audit — can be 100 to 1000 times the cost of the O-ring itself. Below is a factual comparison to help you make the correct specification decision.
| Parameter | FDA Compliant VMQ (This Page) | Non-FDA Commercial VMQ |
|---|---|---|
| Regulatory Compliance | FDA 21 CFR 177.2600 certified | No food contact compliance |
| Extractables Tested | Yes — n-hexane ≤ 175 mg/dm², water ≤ 20 mg/dm² | Not tested for food simulants |
| Compound Certificate | Provided with every batch (MTR included) | Not available |
| Food Safety | Non-toxic, odourless, tasteless — zero migration risk | May contain plasticisers, fillers, or curatives that migrate into food |
| Colour Coding | Red, translucent, white — regulatory identification | Any colour — no compliance significance |
| Legal for Food Contact | Yes — in US, India (FSSAI referenced), EU (subject to EU 1935/2004) | No — illegal for food contact in regulated markets |
| Audit Trail | Full batch traceability with MTR | No documentation |
| Typical Price Premium | 30-50% above commercial grade | Baseline (cheapest VMQ) |
| Risk if Used in Food Equipment | Zero regulatory risk with proper documentation | Product recall · Regulatory action · Legal liability · Batch rejection |
FDA Compliant Silicone O-Ring Colour Coding — What Each Colour Means
Colour coding is not decorative — it is a regulatory identification system used on food processing production floors to instantly identify which O-rings are FDA compliant and which are not. During food safety audits, inspectors verify that installed O-rings match the colour coding specified in the food plant’s HACCP documentation. Using the wrong colour O-ring is an audit finding.
Red
Standard FDA food grade. Most common colour for food processing, dairy, and beverage equipment. Instant identification on the factory floor.
Translucent
High-purity FDA VMQ. Used where visual inspection for contamination is required — pharma food, nutraceutical, and biotech food applications.
White
FDA + USP Class VI dual-compliant. Maximum visual contrast for clean room particle detection. Pharma food and sterile food applications.
Blue
Metal-detectable FDA VMQ. Contains ferromagnetic particles for inline metal detector detection. Mandatory for HACCP food safety compliance.
FDA Compliant Silicone O-Ring Types — Selecting the Correct Grade for Your Application
FDA 21 CFR 177.2600 compliance is the baseline requirement for food contact. Within FDA compliance, there are sub-grades that address additional requirements for specific food industry applications. Selecting the correct sub-grade prevents both over-specification (wasting money on certifications you do not need) and under-specification (risking audit failure).
FDA Food Grade — Standard
FDA 21 CFR 177.2600- Peroxide-cured VMQ — standard economical curing process
- Red or translucent colour-coded identification
- Food processing, dairy, beverage, confectionery, kitchen equipment
- 50 Shore A standard; 40–70 Shore A available
- MOQ: 1,000 Nos per size per grade
FDA + USP Class VI Dual Grade
FDA + USP Class VI- Compound passes both FDA 21 CFR 177.2600 AND USP Class VI
- White or translucent for clean room contamination detection
- Pharma food, nutraceutical, dietary supplement equipment
- Extractables and leachables documentation on request
- See: USP Class VI O-Ring page
Metal-Detectable FDA Grade
FDA + HACCP- FDA-compliant VMQ loaded with ferromagnetic detectable particles
- Detected by inline metal detectors on food processing lines
- Blue colour — maximum visual contrast against food products
- Mandatory for HACCP-compliant food factories
- See: Food Grade Silicone O-Ring page
Platinum-Cured FDA Grade
FDA + Platinum Cure- Platinum-catalysed curing — zero peroxide decomposition residues
- Ultra-low extractables for sensitive food and pharma food applications
- Organoleptic (taste/odour) testing passed — zero sensory impact on food
- Premium grade for infant formula, dairy, and high-purity food
High-Tear FDA Grade
FDA + High Tear- FDA-compliant VMQ with 2–3x standard tear propagation resistance
- Semi-dynamic sealing in food equipment where standard VMQ tears
- Slow-rotating valve stems, door gaskets, lid seals with movement
- Tear strength 25–40 kN/m vs 10–15 kN/m for standard VMQ
Custom FDA Grade to Drawing
FDA + Custom- Any non-standard ID x CS dimension, produced to your drawing
- ±0.05 mm tolerance on custom dimensions
- FDA-compliant compound with MTR confirming 21 CFR 177.2600
- Private branding with your part number and batch traceability
🏭 OEM & Bulk Supply — Custom FDA Compliant Silicone O-Rings to Your Drawing
We supply FDA compliant silicone O-rings sourced from verified manufacturers whose compounds are certified to FDA 21 CFR 177.2600 — every supplier vetted for compound consistency, extractables compliance, and batch traceability. This gives you:
- ✅ Verified FDA compliance — compound manufacturer’s certificate on file; MTR confirming FDA 21 CFR 177.2600 included with every batch
- ✅ Custom dimensions — any ID x CS outside standard DIN/AS568 ranges, produced to your drawing with ±0.05 mm tolerance
- ✅ Batch consistency — identical compound, hardness, and extractables profile across production batches for food machinery OEMs
- ✅ Sample reverse-engineering — send your worn or failed FDA O-ring; we identify the compound grade and supply compliant replacements
- ✅ Private branding — O-rings packed in your brand with your part number and batch traceability documentation
MOQ: 1,000 Nos per size per grade · MOV: ₹50,000 per order
💰 FDA Compliant Silicone O-Ring Price — Approx. Ex-Works Ahmedabad, GST Extra (Valid 30 Days · Firm Quote on WhatsApp)
FDA 21 CFR 177.2600 Compliant Silicone O-Ring Price — DIN 3771 Standard Sizes
Prices below for VMQ FDA 21 CFR 177.2600 compliant, peroxide-cured, 50–70 Shore A, red/translucent, DIN 3771 standard sizes, MOQ 1,000 Nos, MOV ₹50,000. Platinum-cured and metal-detectable grades priced higher.
| ID Range (mm) | Cross Section (mm) | DIN 3771 Ref | Price / Pc (INR) | MOQ |
|---|---|---|---|---|
| 5 – 14 | 1.5 – 2.0 | A 5×1.5 to 14×2 | ₹4 – ₹10 | 1,000 Nos |
| 15 – 30 | 2.0 – 2.5 | A 15×2 to 30×2.5 | ₹6 – ₹15 | 1,000 Nos |
| 32 – 60 | 2.5 – 3.5 | A 32×3.5 to 60×3.5 | ₹12 – ₹28 | 1,000 Nos |
| 65 – 100 | 3.5 – 5.0 | A 65×5.3 to 100×5.3 | ₹22 – ₹50 | 1,000 Nos |
| 105 – 200 | 5.0 – 7.0 | A 109×5.3 to 200×7 | ₹40 – ₹100 | 1,000 Nos |
| 210 – 350 | 5.0 – 7.0 | A 210×7 to 350×7 | ₹85 – ₹260 | 1,000 Nos |
| 360 – 500 | 7.0 – 12.0 | B / Cord & Vulcanise | ₹200 – ₹750 | 1,000 Nos |
FDA Compliant Silicone O-Ring Grade Price Comparison
Indicative prices for ID 25–50 mm x CS 2.5–3.5 mm, MOQ 1,000 Nos, MOV ₹50,000, DIN 3771.
FDA Food Grade — Standard
Peroxide-Cured · Red / Translucent- FDA 21 CFR 177.2600 certified compound
- Standard food processing, dairy, beverage
- Most economical FDA compliant grade
- MTR included with every batch
FDA + USP Class VI
Dual Compliant · White / Translucent- FDA + USP Class VI biocompatibility
- Pharma food, nutraceutical, dietary supplement
- 30-50% premium over standard FDA
- Extractables/leachables data on request
Platinum-Cured FDA
Addition-Cure · Zero Peroxide Residues- Ultra-low extractables — zero organoleptic impact
- Infant formula, high-purity dairy, sensitive food
- 80-150% premium over standard FDA
- ISO 10993 data available on request
Metal-Detectable FDA
HACCP Compliant · Blue Colour- FDA + ferromagnetic detectable particles
- HACCP food safety — inline metal detector compatible
- 60-100% premium over standard FDA
- Blue colour — maximum visual contrast
High-Tear FDA
Reinforced · Semi-Dynamic Seals- FDA + 2-3x standard tear strength
- Food equipment with movement — valve stems, lids
- 20-40% premium over standard FDA
- Tear strength 25-40 kN/m
Commercial VMQ (Non-FDA)
⚠️ NOT for Food Contact- No FDA 21 CFR 177.2600 compliance
- HVAC, hot air, electrical — non-food only
- 30-40% lower than FDA grade
- Must never be used in food equipment
💡 Pricing note: Above rates are approximate for standard DIN 3771 sizes at MOQ 1,000 Nos per size (MOV ₹50,000 per order). Custom non-standard sizes priced per drawing — share your drawing on WhatsApp for a quote within 24 hours. VMQ raw material prices fluctuate — firm quotes on WhatsApp. For mixed-size project BOMs: WhatsApp your BOM — project pricing within 2 hours.
📥 Need FDA Compliant Silicone O-Ring Price? — WhatsApp, Get Quote in 2 Hours
Tell us: FDA Grade (Standard / USP Class VI / Platinum-Cured / Metal-Detectable) · Size (ID x CS or AS568 dash) · Quantity · Delivery city
📲 WhatsApp Your Requirement 📧 Email InquiryFDA Compliant Silicone O-Ring Applications — Where Food Contact Compliance Is Mandatory
Every piece of food processing equipment that has a rubber seal in direct or indirect contact with food requires FDA compliant O-rings. Below are the most common food industry applications in India where our FDA compliant silicone O-rings are installed.
Food Processing Mixers & Blenders
Shaft seals, lid gaskets, and discharge valve seals in ribbon blenders, planetary mixers, and high-shear mixers. FDA red/translucent. 40-80mm ID common.
Dairy Pasteurisation & Homogenisation
Tri-clamp ferrule seals, plate heat exchanger gaskets, homogeniser valve seals. FDA red. 20-60mm ID. CIP-compatible.
Beverage Bottling & Canning
Filler nozzle seals, carbonation valve seals, conveyor guide seals. FDA red/translucent. Metal-detectable for HACCP lines.
Confectionery & Chocolate Processing
Tempering machine seals, enrober gates, moulding equipment. FDA red. Temperature cycling from -20°C to +180°C.
Pharmaceutical Food Equipment
Nutraceutical mixers, dietary supplement reactors, infant formula processing. FDA + USP Class VI dual-compliant. White/translucent. See: O-Ring Pharmaceutical Equipment page
Commercial Kitchen Equipment
Steam oven door seals, food warmer gaskets, dishwasher seals, coffee machine brew group seals. FDA red/translucent. Temperature -40°C to +200°C.
Peroxide-Cured vs Platinum-Cured FDA Silicone O-Ring — Which Do You Need?
The curing method determines the extractables profile of the FDA compliant O-ring. For most food processing applications, peroxide-cured FDA VMQ is sufficient and economical. For applications where even trace peroxide residues are unacceptable — infant formula, organoleptic-sensitive products, and pharma food — platinum-cured is required.
| Parameter | Peroxide-Cured FDA VMQ | Platinum-Cured FDA VMQ |
|---|---|---|
| Curing Process | Organic peroxide catalyst (e.g. DCP) — decomposes during cure, leaving trace byproducts | Platinum (Pt) catalyst — addition-cure reaction produces zero decomposition byproducts |
| FDA 21 CFR 177.2600 | Compliant | Compliant |
| Extractables Level | Low — within FDA limits, but trace peroxide residues detectable | Ultra-low — zero peroxide residues, significantly below FDA limits |
| Organoleptic Impact | Minimal — acceptable for most food applications | Zero — no taste or odour transfer, even to sensitive foods |
| Best Application | Standard food processing, dairy, beverage, kitchen equipment | Infant formula, dairy high-purity, pharma food, organoleptic-sensitive products |
| Price Premium | Baseline FDA price | 80-150% above peroxide-cured |
| Colour Availability | Red, translucent, white, orange | Translucent, white (high-purity colours) |
ℹ️ Recommendation: If your food product does not have strict organoleptic (taste/odour) requirements, peroxide-cured FDA VMQ is the correct and most economical choice. If your product is taste-sensitive (infant formula, dairy, premium beverages, pharma food), specify platinum-cured. We help you select the correct cure method at inquiry — no over-specification, no under-specification.
FDA Compliant Silicone O-Ring Dimensional Standards
FDA compliance applies to the compound, not the dimensions. FDA compliant O-rings are available in all standard O-ring sizes — the FDA certification is independent of size or standard. Below are the dimensional standards available.
| Standard | System | How to Specify | Common Food Industry Use |
|---|---|---|---|
| DIN 3771 | Metric (mm) | ID x CS — e.g. “40 x 3.5 VMQ 50 Shore A FDA DIN 3771” | Most Indian and European food processing equipment; metric sanitary fittings |
| AS568 | Imperial (inch) | Dash number — e.g. “-214 AS568 VMQ FDA” | US-standard sanitary Tri-Clamp fittings; American-designed food equipment |
| ISO 3601 | Metric (mm) | Size code per ISO table | International projects — dimensionally equivalent to DIN 3771 in most sizes |
| JIS B2401 | Metric (mm) | P-series or G-series | Japanese OEM food and packaging machinery |
| 3-A Sanitary | Imperial (inch) | Tri-Clamp ferrule sizes | Dairy and food sanitary fittings — AS568 dash sizes for Tri-Clamp |
| Custom Drawing | Any | ID x CS + tolerance + Shore A + FDA grade | Non-standard sizes for any OEM — produced to your drawing |
FDA Silicone O-Ring Compatibility with CIP and SIP Cleaning Processes
Food processing equipment is cleaned using CIP (Clean-In-Place) and sterilised using SIP (Steam-In-Place) processes. The O-ring compound must withstand these cleaning regimes without degrading, swelling, or losing its FDA compliance. Below is the chemical compatibility guide for FDA compliant VMQ with common CIP/SIP media.
| CIP/SIP Media | Concentration | Temperature | VMQ Compatibility | Notes |
|---|---|---|---|---|
| Caustic NaOH | Up to 2% | Up to 95°C | ✅ Excellent | Standard CIP caustic wash — most food plants |
| Phosphoric Acid | Up to 2% | Up to 95°C | ✅ Excellent | Acid CIP for mineral scale removal |
| Nitric Acid | Up to 2% | Up to 95°C | ✅ Good | Acid CIP — passivation of stainless steel |
| Peracetic Acid (PAA) | Up to 0.5% | Up to 40°C | ✅ Excellent | Sanitiser — food line disinfection |
| Low-Pressure Steam (SIP) | Up to 3 bar | Up to 130°C | ✅ Good | Standard SIP sterilisation cycle |
| High-Pressure Steam | Above 3 bar | Above 130°C | ❌ Not Recommended | Accelerates VMQ degradation — consider EPDM for high-pressure steam SIP |
| Chlorine / Hypochlorite | Up to 200 ppm | Ambient | ⚠️ Fair | Short contact acceptable; extended exposure degrades VMQ surface |
Why Food Processing OEMs Choose KELOR for FDA Compliant Silicone O-Rings
📋
MTR with Every Batch
Material Test Report confirming FDA 21 CFR 177.2600 compound compliance included free with every order — no extra charge, no exceptions.
🧪
Compound Certificate on File
VMQ compound manufacturer’s FDA compliance certificate maintained on file for traceability. Available for your quality audit documentation on request.
🏭
Verified Source Model
Sourced from verified manufacturers with proven FDA compound certifications. 20-35% savings vs multi-layer trading at equal compound quality.
✅
Batch Traceability
Every batch tracked from compound manufacturer through moulding to delivery. Batch traceability number on packaging matches MTR documentation.
📐
Custom to Drawing
Non-standard FDA compliant O-rings produced to your drawing with ±0.05 mm tolerance. Same FDA compliance, custom dimensions.
🧾
GST Invoice & Documentation
GST invoice (GSTIN: 24AKLPP6499B1ZT), material declaration, and batch traceability — everything your food safety quality audit requires.
How to Order FDA Compliant Silicone O-Rings from KELOR
Specify Grade & Size
FDA grade (Standard / USP Class VI / Platinum / Metal-Detectable), size (ID x CS or AS568 dash), Shore A, colour, quantity, delivery location.
Get Quote + MTR Confirmation
We confirm compound availability, FDA compliance documentation, per-piece price, and delivery timeline. MTR sample provided on request before order.
Confirm & Pay
Proforma invoice with GST. Bank transfer or UPI. 50% advance for standard sizes. 100% advance for custom-to-drawing orders.
Dispatch with MTR
Ahmedabad: same-day dispatch. Gujarat: 1-2 days. Pan India: 3-5 days. MTR and batch traceability included in shipment.
🔗 Ready to order? Submit your FDA compliant silicone O-ring requirement through our Request for Quote form — or WhatsApp directly at +91 93135 43530 for immediate response.
Get FDA Compliant Silicone O-Ring Quote
📩 Request Quote — FDA Compliant Silicone O-Ring
FDA Compliant Silicone O-Ring India — Frequently Asked Questions
What does “FDA compliant silicone O-ring” mean?
An FDA compliant silicone O-ring is moulded from VMQ (silicone rubber) compound whose formulation has been certified by the compound manufacturer to meet the extractables and compositional requirements of FDA 21 CFR 177.2600 — the US regulation governing rubber articles intended for repeated use in contact with food. This certification ensures that when the O-ring is in contact with food under normal service conditions, no harmful substances migrate from the rubber into the food at levels exceeding the regulatory limits. The compound must pass n-hexane extractables testing (≤ 175 mg/dm²) and distilled water extractables testing (≤ 20 mg/dm²). FDA compliance is a compound-level property — it cannot be verified by inspecting the finished O-ring alone; it requires documentation from the compound manufacturer.
Is FDA 21 CFR 177.2600 compliance required for food contact O-rings in India?
While India’s FSSAI does not have its own rubber food-contact regulation equivalent to FDA 21 CFR 177.2600, Indian food processing OEMs and multinational food companies operating in India universally specify FDA 21 CFR 177.2600 compliance as the de facto standard for food-contact rubber components. FSSAI references international food-contact material standards for imported food processing equipment. Most food safety audits in India (by companies, third-party auditors, and international certification bodies like BRC, IFS, and FSSC 22000) require documented FDA compliance for rubber seals in food contact. If your food processing equipment has rubber seals in food contact and those seals are not FDA documented, you will receive an audit finding.
What is the difference between “food grade silicone” and “FDA compliant silicone”?
“Food grade” is a general, unregulated marketing term. Any supplier can call their silicone “food grade” without providing any test data or regulatory compliance documentation. “FDA compliant” specifically means the compound has been tested and certified to meet FDA 21 CFR 177.2600 extractables limits, with documentation to prove it. The difference is documentation — a “food grade” claim without an MTR referencing FDA 21 CFR 177.2600 is legally meaningless. Always demand the MTR with the CFR citation. If the supplier cannot produce it, the O-ring is not FDA compliant regardless of colour, appearance, or verbal assurance.
Do you provide MTR (Material Test Report) with FDA compliant silicone O-ring orders?
Yes — MTR confirming FDA 21 CFR 177.2600 compound compliance is included free with every batch. The MTR covers: VMQ compound grade, FDA regulation reference (21 CFR 177.2600), hardness (Shore A), tensile strength, elongation, compression set, colour, and batch traceability number. For USP Class VI dual-compliant grades, the MTR also references USP Class VI biocompatibility chapters. Compound manufacturer’s original certification is maintained on file and available for your quality audit documentation on request.
What is the price of FDA compliant silicone O-ring in India?
VMQ FDA 21 CFR 177.2600 compliant silicone O-ring price India approximate ex-works Ahmedabad for standard peroxide-cured FDA grade at MOQ 1,000 Nos (MOV ₹50,000): ID 5-14mm Rs 4-10 per piece, ID 15-30mm Rs 6-15, ID 32-60mm Rs 12-28, ID 65-100mm Rs 22-50, ID 105-200mm Rs 40-100, ID 210-350mm Rs 85-260, ID 360-500mm Rs 200-750. Platinum-cured FDA is 80-150% higher. Metal-detectable FDA is 60-100% higher. Commercial non-FDA grade is 30-40% lower — but must never be used in food contact. Firm quote on WhatsApp within 2 hours.
Can I use FDA compliant silicone O-rings for pharmaceutical equipment?
It depends on the type of pharmaceutical equipment. For pharmaceutical food applications (nutraceuticals, dietary supplements, infant formula), FDA 21 CFR 177.2600 plus USP Class VI dual compliance is typically required. For pharmaceutical drug manufacturing equipment (reactors, fermenters, chromatography columns), USP Class VI compliance alone is the minimum — FDA food contact compliance is not sufficient because drug contact has different extractables and leachables requirements than food contact. See our O-Ring for Pharmaceutical Equipment page for complete pharma sealing guidance.
What colour should my FDA compliant silicone O-ring be?
Colour coding serves regulatory identification on food production floors. Red = standard FDA food grade — the most common colour, instantly recognised on factory floors. Translucent = high-purity FDA VMQ — permits visual inspection for contamination, used in pharma food and biotech food. White = FDA + USP Class VI dual-compliant — maximum visual contrast for clean room particle detection. Blue = metal-detectable FDA — contains ferromagnetic particles, mandatory for HACCP lines, contrasts against all food products. The colour of your installed O-rings should match your HACCP plan documentation — auditors check this during food safety inspections.
What temperature range do FDA compliant silicone O-rings handle?
FDA compliant VMQ silicone O-rings operate from -60°C to +230°C continuous — the widest temperature range of any FDA-compliant O-ring elastomer. This covers virtually all food processing temperature conditions in India: frozen food storage (-40°C), cold chain logistics (-25°C), ambient processing (25-40°C), hot filling (80-95°C), CIP cleaning (up to 95°C), low-pressure SIP (up to 130°C), oven door seals (up to 200°C), and autoclave gaskets (up to 230°C short-term). For continuous steam above 130°C, VMQ compression set increases — consider EPDM for high-pressure steam SIP applications.
What is the minimum order quantity for FDA compliant silicone O-rings?
MOQ is 1,000 Nos per size per grade per batch for both standard DIN 3771 / AS568 sizes and custom sizes per drawing. MOV (minimum order value) is ₹50,000 per order. This MOQ accommodates food processing OEMs who need many sizes in smaller quantities per size. First article samples (5-10 Nos) provided before bulk commitment so you can verify compound and dimensions. Mixed size and mixed grade orders welcome — single GST invoice for all items.
How do I know if my current silicone O-rings are FDA compliant?
Check for documentation. If your current supplier provided an MTR (Material Test Report) specifically citing FDA 21 CFR 177.2600 extractables compliance with batch traceability, your O-rings are FDA compliant. If no such documentation exists, they are not FDA compliant — regardless of colour, appearance, or verbal claims. Request the MTR from your supplier. If they cannot produce it, replace the O-rings with documented FDA compliant ones before your next food safety audit. We provide MTR with every batch — send us your sizes and we quote replacements with full compliance documentation.
Related Pages — Silicone O-Ring Resources
📋 KELOR Krishna Industries — FDA Compliant Silicone O-Ring Supplier India
Ahmedabad, Gujarat · FDA 21 CFR 177.2600 Certified · MTR with Every Batch · Since 2017 · Pan India Dispatch
📲 WhatsApp +91 93135 43530 📧 [email protected] 📋 Request Quote Online