FDA 510(k)

Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)

K-Number: K212789 · 2021-12-01

Applicant5r Med Instruments (Chengdu) Co., Ltd.

Decision Date2021-12-01

Product CodeLZA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) is a medical device manufactured by 5r Med Instruments (Chengdu) Co., Ltd.. It received FDA 510(k) clearance on 2021-12-01 under approval number K212789. 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 Examination Gloves (Tested for Use with Chemotherapy Drugs)?

Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) is a medical device that received FDA 510(k) clearance on 2021-12-01. It is manufactured by 5r Med Instruments (Chengdu) Co., Ltd.. The 510(k) number is K212789.

When was Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) approved by the FDA?

Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) received FDA 510(k) clearance on 2021-12-01, under approval number K212789.

What company makes Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)?

Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) is manufactured by 5r Med Instruments (Chengdu) Co., Ltd..

What is the FDA product code for Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)?

The FDA product code for Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) is LZA.

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Other Devices by 5r Med Instruments (Chengdu) Co., Ltd.

K210776Nitrile Examination Gloves

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.