Certificates and Supporting Documents for Buyer Review
A clearer document map for importers and distributors reviewing FDA Test Report, EN455 SGS report, ISO 13485, CE documentation and product files before quotation.
Available files and what buyers should verify.
| Item | Details |
|---|---|
| FDA Test Report | Related product: Nitrile gloves / relevant disposable glove products Market: USA buyer review Document type: Product testing support document Open PDF |
| Nitrile Gloves Document | Related product: Nitrile gloves Market: General buyer review Document type: Product file Open PDF |
| Latex Gloves Document | Related product: Latex gloves Market: General buyer review Document type: Product file Open PDF |
| Vinyl Gloves Document | Related product: Vinyl gloves Market: General buyer review Document type: Product file Open PDF |
| ISO 13485 | Related product: Factory quality management system Market: Medical device supply-chain reference Document type: Factory system certificate Open PDF |
| EN455 Test Report from SGS | Related product: Medical examination glove reference Market: European buyer review Document type: Test report Open PDF |
| Nitrile Gloves CE | Related product: Nitrile gloves Market: European buyer review Document type: CE documentation Open PDF |
| Powderfree FDA 510K | Related product: Powder-free glove documentation Market: USA medical buyer review Document type: Regulatory document Open PDF |
| Pure Nitrile Gloves Data Sheet | Related product: Nitrile gloves Market: Specification review Document type: Data sheet Open PDF |
| Gloves Test Report | Related product: Disposable gloves Market: Buyer review Document type: Supporting test report Open PDF |
Match each certificate or report to the quoted glove
| Available document | Buyer verification point | Relevant buying center |
|---|---|---|
| FDA Test Report | Report scope, named product, test method and market use | Nitrile gloves |
| EN455 SGS Test Report | Clauses tested, product identity, issuing laboratory and date | Nitrile gloves |
| ISO 13485 | Certificate holder, certified activities, issue and expiry dates | Nitrile glove center |
| Nitrile Gloves CE File | Manufacturer, product, conformity route and current applicability | Food service / industrial |
| Pure Nitrile Data Sheet | Material and specification relationship to the approved sample | Nitrile specifications |
Document control note: website availability does not mean every document applies to every glove. The quotation should identify the SKU, intended use, destination market and document set reviewed by the buyer.
How to read these documents.
Can I use these documents for customs or registration?
Do not rely on any document until Amy confirms the exact product, SKU, batch, standard, destination market and current validity.
Are the files proof that every glove is certified?
No. Documents must be matched to the exact product and intended use. Some files apply only to specific glove types or standards.
Can EASTGLOVES provide additional documents?
Available documents depend on product, order and market requirement. Send your destination country and intended use for confirmation.
Ask Amy to Match Documents to Your Product
Send Amy your product type, size, color, quantity, destination country and OEM packaging requirements. We typically respond within 24 hours.