FDA 510(k)

Disposable Nitrile Inspection Gloves (Tested for Use with Chemotherapy Drugs)

K-Number: K214056 · 2022-09-20

ApplicantMezorrison Medical Technology (Dongying) Co., Ltd.

Decision Date2022-09-20

Product CodeLZA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Disposable Nitrile Inspection Gloves (Tested for Use with Chemotherapy Drugs) is a medical device manufactured by Mezorrison Medical Technology (Dongying) Co., Ltd.. It received FDA 510(k) clearance on 2022-09-20 under approval number K214056. 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 Disposable Nitrile Inspection Gloves (Tested for Use with Chemotherapy Drugs)?

Disposable Nitrile Inspection Gloves (Tested for Use with Chemotherapy Drugs) is a medical device that received FDA 510(k) clearance on 2022-09-20. It is manufactured by Mezorrison Medical Technology (Dongying) Co., Ltd.. The 510(k) number is K214056.

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

Disposable Nitrile Inspection Gloves (Tested for Use with Chemotherapy Drugs) received FDA 510(k) clearance on 2022-09-20, under approval number K214056.

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

Disposable Nitrile Inspection Gloves (Tested for Use with Chemotherapy Drugs) is manufactured by Mezorrison Medical Technology (Dongying) Co., Ltd..

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

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

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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

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