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Nitrile Glove Certification: FDA 510(k) & EN 455

FDA 510(k), EN 455 and AQL explained — what these certifications mean for nitrile gloves and which files to verify.

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需要考虑的事项

01

FDA 510(k) clearance for the US market

Nitrile examination gloves sold in the US are regulated as medical devices and require FDA 510(k) clearance. The clearance confirms the glove is substantially equivalent to a legally marketed device. Confirm the supplier's FDA 510(k) clearance and that the specific model is covered before ordering for the US market. The file must name the exact model you are importing, and you should keep a copy for your own customs and market-entry process.

  • FDA 510(k) clearance is required for the US market
  • The file must name the exact model you import
  • Keep a copy for customs and market entry
02

EN 455 for the European market

EN 455 is the European standard for single-use medical examination gloves. It covers freedom from holes, physical properties (size and strength) and biocompatibility. A glove that meets EN 455 is suitable for medical examination use in Europe. For European export, confirm the glove is tested to EN 455 and that the performance values match your application.

  • EN 455 is the European standard for exam gloves
  • Covers freedom from holes, size and strength
  • Confirm EN 455 for European export
03

AQL: the quality acceptance level

AQL (acceptable quality level) is the maximum number of defective gloves allowed in a batch. A lower AQL means a stricter quality standard — for example, AQL 1.5 allows fewer defects than AQL 2.5. Medical-grade gloves typically use AQL 1.5 or lower. Confirm the AQL on the specification sheet, because it directly affects the quality of the gloves you receive in a bulk order.

  • AQL is the maximum allowed defect rate in a batch
  • A lower AQL means a stricter quality standard
  • Medical-grade gloves typically use AQL 1.5 or lower
04

What to verify before you buy

Ask for the certification file covering the exact model, the standard it meets, the issuing body and the validity period. Verify the file is current and matches your target market before placing an order. A supplier who cannot produce the file for the exact model should be treated as unverified, regardless of price. Confirm the AQL and the powder-free option on the specification sheet.

  • Request the file for the exact model
  • Check the standard, issuing body and validity period
  • A supplier without the exact-model file is unverified
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买家常见问题

常见采购问题

What is FDA 510(k) clearance?+

FDA 510(k) clearance is the US regulatory approval for medical devices, including examination gloves. Confirm the gloves carry this clearance for the US market.

What does EN 455 cover?+

EN 455 is the European standard for single-use medical examination gloves, covering freedom from holes, physical properties and biocompatibility.

What is a good AQL for medical gloves?+

Medical-grade gloves typically use AQL 1.5 or lower, which allows fewer defects than AQL 2.5. Confirm the AQL on the specification sheet.

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  • CE / FDA 认证文件
  • 最小起订量 (MOQ)、包装及确认交期
  • OEM / 贴牌定制选项，适配您的品牌
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