FDA Compliant Silicone O-Ring India — 21 CFR 177.2600 Certified VMQ Supplier
FDA 21 CFR 177.2600 compliant Silicone O-Rings sourced from verified manufacturers — non-toxic, odourless, tasteless, and safe for repeated food contact. Colour-coded red, translucent, or white. VMQ temperature range: -60°C to +230°C. Available in DIN 3771 metric, AS568 inch, and ISO 3601 standards (ID 1 mm to 500 mm). 50 Shore A standard, with peroxide-cured and platinum-cured options for food processing, dairy, beverage, confectionery, and kitchen equipment seals.
MOQ: 1,000 Nos | MOV: ₹50,000 | MTR: Included with Every Batch | GST Invoice: 24AKLPP6499B1ZT | Pan India Dispatch
✅ What “FDA Compliant Silicone O-Ring” Actually Means
An FDA compliant silicone O-ring is moulded from a 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. This is the US Code of Federal Regulations title governing rubber articles intended for repeated contact with food. This is not a voluntary marketing claim — it is a regulatory compliance declaration carrying legal liability. Every batch we supply includes a Material Test Report (MTR) confirming this 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, ensuring no harmful substances migrate into food.
- ✅ What it proves: The VMQ compound is non-toxic, odourless, tasteless, and will not contaminate food under repeated contact at service temperatures.
- 🚫 What it does NOT cover: Pharmaceutical drug contact (requires USP Class VI), medical implant contact (requires ISO 10993), or drinking water contact (requires NSF/WRAS).
FDA Compliant Silicone O-Ring Product Images — KELOR Supply Range
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. 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. Second, the distilled water extractables test — when immersed in distilled water for 24 hours at reflux, total extractables must not exceed 20 mg/dm².
How to Verify Your Silicone O-Ring Is Genuinely FDA Compliant
Verifying FDA compliance 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 compliant.
2. Check Compound Certificate
The MTR must reference the VMQ compound manufacturer’s certification, not just the O-ring moulding shop’s claim. Compliance is a compound-level property.
3. Verify Extractables Data
The certificate should state n-hexane extractables ≤ 175 mg/dm² and distilled water extractables ≤ 20 mg/dm². Missing data means unverified compliance.
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 major red flag.
5. Confirm the Regulation Number
The MTR must specifically cite “FDA 21 CFR 177.2600.” Generic claims like “food safe” without the CFR reference are legally meaningless.
6. Check Colour Coding
FDA-compliant VMQ is colour-coded for line identification. Red = standard FDA. Translucent = high-purity FDA. White = FDA + USP Class VI pharma.
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. However, 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 due to batch rejection, product recall, and regulatory action.
| 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 or fillers that migrate |
| Legal for Food Contact | Yes — in US, India (FSSAI referenced), EU | No — illegal for food contact in regulated markets |
| Audit Trail | Full batch traceability with MTR | No documentation |
| Risk if Used in Food Equipment | Zero regulatory risk with proper documentation | Product recall, regulatory action, legal liability |
FDA Compliant Silicone O-Ring Colour Coding — What Each Colour Means
Colour coding is a regulatory identification system used on food processing production floors to instantly identify which O-rings are FDA compliant. During food safety audits, inspectors verify that installed O-rings match the colour coding specified in the plant’s HACCP documentation.
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 applications.
White
FDA + USP Class VI dual-compliant. Maximum visual contrast for clean room particle detection. Pharma food and sterile 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
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.
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
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
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
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
- Premium grade for infant formula, dairy, and high-purity food
🏭 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
- ✅ 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 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 |
📥 Need FDA Compliant Silicone O-Ring Price? Get a 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
Food Processing Mixers & Blenders
Shaft seals, lid gaskets, and discharge valve seals in ribbon blenders 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.
Pharmaceutical Food Equipment
Nutraceutical mixers, dietary supplement reactors, infant formula processing. FDA + USP Class VI dual-compliant. White/translucent.
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 — 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, high-purity dairy, pharma food, sensitive products |
| Price Premium | Baseline FDA price | 80-150% above peroxide-cured |
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.
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.
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.
Get FDA Compliant Silicone O-Ring Quote
📩 Request Quote — FDA Compliant Silicone O-Ring
FDA Compliant Silicone O-Ring India — Frequently Asked Questions
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 📧 sales@kelorvalves.com 📋 Request Quote Online