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FDA 510(k)

Nitrile Examination Gloves (Powder free, Blue)

K-Number: K213029 · 2021-12-14

ApplicantWeihai Hongyu Nonwoven Fabric Products Co., Ltd.
Decision Date2021-12-14
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Nitrile Examination Gloves (Powder free, Blue) is a medical device manufactured by Weihai Hongyu Nonwoven Fabric Products Co., Ltd.. It received FDA 510(k) clearance on 2021-12-14 under approval number K213029. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Nitrile Examination Gloves (Powder free, Blue)?

Nitrile Examination Gloves (Powder free, Blue) is a medical device that received FDA 510(k) clearance on 2021-12-14. It is manufactured by Weihai Hongyu Nonwoven Fabric Products Co., Ltd.. The 510(k) number is K213029.

When was Nitrile Examination Gloves (Powder free, Blue) approved by the FDA?

Nitrile Examination Gloves (Powder free, Blue) received FDA 510(k) clearance on 2021-12-14, under approval number K213029.

What company makes Nitrile Examination Gloves (Powder free, Blue)?

Nitrile Examination Gloves (Powder free, Blue) is manufactured by Weihai Hongyu Nonwoven Fabric Products Co., Ltd..

What is the FDA product code for Nitrile Examination Gloves (Powder free, Blue)?

The FDA product code for Nitrile Examination Gloves (Powder free, Blue) is LZA.

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Other Devices by Weihai Hongyu Nonwoven Fabric Products Co., Ltd.

K212807Surgical Masks K214088Disposable Surgical Gown K220133Sterilization Wraps

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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