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FDA 510(k)

Nitrile Gloves (Model: NE01)

K-Number: K212840 · 2021-12-11

ApplicantByd Auto Industry Company Limited
Decision Date2021-12-11
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Nitrile Gloves (Model: NE01) is a medical device manufactured by Byd Auto Industry Company Limited. It received FDA 510(k) clearance on 2021-12-11 under approval number K212840. 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 Gloves (Model: NE01)?

Nitrile Gloves (Model: NE01) is a medical device that received FDA 510(k) clearance on 2021-12-11. It is manufactured by Byd Auto Industry Company Limited. The 510(k) number is K212840.

When was Nitrile Gloves (Model: NE01) approved by the FDA?

Nitrile Gloves (Model: NE01) received FDA 510(k) clearance on 2021-12-11, under approval number K212840.

What company makes Nitrile Gloves (Model: NE01)?

Nitrile Gloves (Model: NE01) is manufactured by Byd Auto Industry Company Limited.

What is the FDA product code for Nitrile Gloves (Model: NE01)?

The FDA product code for Nitrile Gloves (Model: NE01) 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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