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FDA 510(k)

Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and Gray Colors

K-Number: K202076 · 2021-03-05

ApplicantShen Wei USA, Inc.
Decision Date2021-03-05
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and Gray Colors is a medical device manufactured by Shen Wei USA, Inc.. It received FDA 510(k) clearance on 2021-03-05 under approval number K202076. 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 Powder Free Flock-Lined Nitrile Examination Glove, Black and Gray Colors?

Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and Gray Colors is a medical device that received FDA 510(k) clearance on 2021-03-05. It is manufactured by Shen Wei USA, Inc.. The 510(k) number is K202076.

When was Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and Gray Colors approved by the FDA?

Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and Gray Colors received FDA 510(k) clearance on 2021-03-05, under approval number K202076.

What company makes Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and Gray Colors?

Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and Gray Colors is manufactured by Shen Wei USA, Inc..

What is the FDA product code for Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and Gray Colors?

The FDA product code for Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and Gray Colors is LZA.

Related Clinical Trials

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Related Devices (Code: LZA)

K161215Brightway Brand Nitrile Examination Gloves, Powder Free, [Sterling/Grey] Tested For Use With Chemotherapy DrugsBrightway Holdings Sdn. Bhd. K161932Powder Free Polychloroprene Examination Glove Blue, Powder Free Polychloroprene Examination Glove PinkTerang Nusa Sdn Bhd K161944Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy DrugsShandong Baisheng Medical Products Co., Ltd. K161074Powder Free Nitrile Examination Gloves Flock-Lined, Black ColorShen Wei (Usa), Inc. K162113Powder Free Nitrile Examination Gloves (Blue)Nam Viet Glove Joint Stock Company K162095Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Original Blue, Cobalt Blue)Yty Industry (Manjung) Sdn Bhd

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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