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How to Read a Disposable Glove Certificate of Conformity (CoC)
Fujian Jixiang E-commerce Co., Ltd
A Certificate of Conformity (CoC) is a document issued by a manufacturer or notified body confirming that a product meets specified regulatory and technical requirements. For disposable gloves, the CoC is the fastest way to verify that a batch meets the claims made on the box.
1. What a CoC Is - and What It Is Not
A CoC is an attestation of compliance. It is not a test report, not an invoice, and not a marketing brochure. It should reference the exact standard, batch or lot number, and the issuing authority. If the CoC does not match the product label, the document is unreliable.
2. Eight Fields to Check on Every Glove CoC
| Field | What to Look For | Why It Matters |
|---|
| Product description | Exact glove type, material, powder-free status, size range | Ensures the CoC covers the SKU you are buying |
| Applicable standards | EN 455, EN 374, ASTM D6319, ASTM D3578, ISO 11193 | Confirms regulatory scope for your market |
| Notified body / lab | Name, address, accreditation (ISO 17025) | Unaccredited labs produce unenforceable certificates |
| Test report numbers | Unique report IDs with dates | Lets you cross-check with the lab |
| Batch / lot number | Must match the shipment label | Traceability and recall management |
| AQL level | AQL 1.5, 0.65, 2.5, 4.0 | Determines defect allowance and medical-grade status |
| Expiry / validity | CoC issue date and validity period | Old CoCs may not reflect current formulation |
| Authorized signature | Signed by quality manager or regulatory representative | Demonstrates accountability |
3. Red Flags That Should Stop the Order
- The CoC has no test report number or the lab is not ISO 17025 accredited.
- The standard referenced is outdated, vague, or incorrect for the product.
- The batch number on the CoC does not match the physical carton label.
- The document is a generic template with no product-specific details.
- The manufacturer refuses to share the original test report or factory quality manual.
4. How to Verify the CoC
Contact the test lab directly using contact details from its official website, not from the CoC itself. Provide the report number and ask for confirmation. For EU CE-marked medical gloves, check the notified body identification number in the NANDO database. For GSO-marked products, verify the registration in the GCC Standardization Organization systems or national authority portals.
5. FAQ
Q: Is a CoC the same as a test report?
A: No. A CoC is a declaration that the product complies with standards. A test report contains the actual measurement data from a lab.
Q: Who can issue a CoC for disposable gloves?
A: A manufacturer can issue a self-declaration for some standards, but medical-grade and PPE claims usually require a notified body or ISO 17025 lab.
Q: How long is a CoC valid?
A: There is no universal expiry, but most buyers accept CoCs issued within 1-2 years. A new formulation, standard update, or material change requires a new CoC.
Q: What does AQL 1.5 on a CoC mean?
A: AQL 1.5 means the accepted quality level allows up to 1.5% defective gloves in the sampled lot. Lower AQL values mean stricter quality.
Q: Can I use a CoC from one country in another market?
A: Not automatically. A CoC must reference the standards recognized in the target market. For example, EN 455 is for the EU; ASTM D6319 is for the US market.