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FDA 510(k)

Nitrile Vinyl Blend Powder Free Examination Gloves (Black)

K-Number: K213574 · 2022-07-12

Decision Date2022-07-12
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Nitrile Vinyl Blend Powder Free Examination Gloves (Black) is the device name listed in this FDA 510(k) record. The listed applicant is Grand Work Plastic Products Co., Ltd.. It received FDA 510(k) clearance on 2022-07-12 under 510(k) number K213574. 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 Vinyl Blend Powder Free Examination Gloves (Black)?

Nitrile Vinyl Blend Powder Free Examination Gloves (Black) is a medical device that received FDA 510(k) clearance on 2022-07-12. The listed applicant is Grand Work Plastic Products Co., Ltd.. The 510(k) number is K213574.

When did Nitrile Vinyl Blend Powder Free Examination Gloves (Black) receive FDA 510(k) clearance?

Nitrile Vinyl Blend Powder Free Examination Gloves (Black) received FDA 510(k) clearance on 2022-07-12, under 510(k) number K213574.

Who is the listed applicant for Nitrile Vinyl Blend Powder Free Examination Gloves (Black)?

The FDA 510(k) record lists Grand Work Plastic Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nitrile Vinyl Blend Powder Free Examination Gloves (Black)?

The FDA product code for Nitrile Vinyl Blend Powder Free Examination Gloves (Black) is LZA.

Other records listing Grand Work Plastic Products Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: LZA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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