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FDA 510(k)

Nitrile Glove

K-Number: K211252 · 2021-06-25

ApplicantJiangsu Dihong Industry and Trade Co., Ltd.
Decision Date2021-06-25
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Nitrile Glove is a medical device manufactured by Jiangsu Dihong Industry and Trade Co., Ltd.. It received FDA 510(k) clearance on 2021-06-25 under approval number K211252. 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 Glove?

Nitrile Glove is a medical device that received FDA 510(k) clearance on 2021-06-25. It is manufactured by Jiangsu Dihong Industry and Trade Co., Ltd.. The 510(k) number is K211252.

When was Nitrile Glove approved by the FDA?

Nitrile Glove received FDA 510(k) clearance on 2021-06-25, under approval number K211252.

What company makes Nitrile Glove?

Nitrile Glove is manufactured by Jiangsu Dihong Industry and Trade Co., Ltd..

What is the FDA product code for Nitrile Glove?

The FDA product code for Nitrile Glove is LZA.

Other Devices by Jiangsu Dihong Industry and Trade Co., Ltd.

K211904Vinyl Glove

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

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

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