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FDA 510(k)

Pro Guard Nitrile Powder Free Examination Glove

K-Number: K213934 · 2022-08-06

ApplicantMedical Glove Co., Ltd.
Decision Date2022-08-06
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Pro Guard Nitrile Powder Free Examination Glove is a medical device manufactured by Medical Glove Co., Ltd.. It received FDA 510(k) clearance on 2022-08-06 under approval number K213934. 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 Pro Guard Nitrile Powder Free Examination Glove?

Pro Guard Nitrile Powder Free Examination Glove is a medical device that received FDA 510(k) clearance on 2022-08-06. It is manufactured by Medical Glove Co., Ltd.. The 510(k) number is K213934.

When was Pro Guard Nitrile Powder Free Examination Glove approved by the FDA?

Pro Guard Nitrile Powder Free Examination Glove received FDA 510(k) clearance on 2022-08-06, under approval number K213934.

What company makes Pro Guard Nitrile Powder Free Examination Glove?

Pro Guard Nitrile Powder Free Examination Glove is manufactured by Medical Glove Co., Ltd..

What is the FDA product code for Pro Guard Nitrile Powder Free Examination Glove?

The FDA product code for Pro Guard Nitrile Powder Free Examination Glove is LZA.

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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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