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FDA 510(k)

Biodegradable DriTek Powder Free Nitrile Examination Glove, Low Dermatitis Potential Claim, Blue

K-Number: K202081 · 2021-03-19

Decision Date2021-03-19
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Biodegradable DriTek Powder Free Nitrile Examination Glove, Low Dermatitis Potential Claim, Blue is the device name listed in this FDA 510(k) record. The listed applicant is Shen Wei USA, Inc.. It received FDA 510(k) clearance on 2021-03-19 under 510(k) number K202081. 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 Biodegradable DriTek Powder Free Nitrile Examination Glove, Low Dermatitis Potential Claim, Blue?

Biodegradable DriTek Powder Free Nitrile Examination Glove, Low Dermatitis Potential Claim, Blue is a medical device that received FDA 510(k) clearance on 2021-03-19. The listed applicant is Shen Wei USA, Inc.. The 510(k) number is K202081.

When did Biodegradable DriTek Powder Free Nitrile Examination Glove, Low Dermatitis Potential Claim, Blue receive FDA 510(k) clearance?

Biodegradable DriTek Powder Free Nitrile Examination Glove, Low Dermatitis Potential Claim, Blue received FDA 510(k) clearance on 2021-03-19, under 510(k) number K202081.

Who is the listed applicant for Biodegradable DriTek Powder Free Nitrile Examination Glove, Low Dermatitis Potential Claim, Blue?

The FDA 510(k) record lists Shen Wei USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Biodegradable DriTek Powder Free Nitrile Examination Glove, Low Dermatitis Potential Claim, Blue?

The FDA product code for Biodegradable DriTek Powder Free Nitrile Examination Glove, Low Dermatitis Potential Claim, Blue is LZA.

Other records listing Shen Wei USA, Inc. 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.

View all 19 devices →

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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