FDA vs CE Certification for Disposable Gloves: A Simple Guide for Importers
If you import disposable gloves into the United States or Europe, documentation matters. The right file depends on destination country, product type and intended use.
FDA Documentation: The US Market
In the United States, disposable gloves marketed for medical examination use are regulated as medical devices. Ask your supplier to confirm the product category and exact SKU documentation.
CE Documentation: The European Market
In Europe, medical examination gloves normally require CE marking and EN455 compliance. Request documents before order confirmation and verify the product details.
ISO 13485: What It Means
ISO 13485 is a quality management system standard for medical device manufacturers. It is not a product certification, but it is a positive indicator of factory quality systems.
EASTGLOVES Documentation
EASTGLOVES provides FDA Test Report, EN455 SGS Test Report, CE documentation and ISO 13485 for relevant products. Confirm the exact product and destination market with Amy.
Quick Comparison Table
| Document | US Market | EU Market | Notes |
|---|---|---|---|
| FDA Test Report | Needed for relevant medical/food use | Not applicable | Confirm SKU is covered |
| CE Certificate | Not applicable | Required for relevant medical gloves | Check expiry and product scope |
| EN455 SGS Test Report | Useful reference | Required for medical gloves | Covers key medical glove tests |
| ISO 13485 | Positive indicator | Positive indicator | Factory system, not product certificate |
| Declaration of Conformity | Not applicable | Required | Supplier-issued EU declaration |
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