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FDA 510(k)

Powder-free Nitrile Examination Gloves Tested for use with Chemotherapy Drugs

K-Number: K220155 · 2022-05-23

ApplicantMotex Healthcare (Anhui) Co., Ltd.
Decision Date2022-05-23
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Powder-free Nitrile Examination Gloves Tested for use with Chemotherapy Drugs is a medical device manufactured by Motex Healthcare (Anhui) Co., Ltd.. It received FDA 510(k) clearance on 2022-05-23 under approval number K220155. 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 Powder-free Nitrile Examination Gloves Tested for use with Chemotherapy Drugs?

Powder-free Nitrile Examination Gloves Tested for use with Chemotherapy Drugs is a medical device that received FDA 510(k) clearance on 2022-05-23. It is manufactured by Motex Healthcare (Anhui) Co., Ltd.. The 510(k) number is K220155.

When was Powder-free Nitrile Examination Gloves Tested for use with Chemotherapy Drugs approved by the FDA?

Powder-free Nitrile Examination Gloves Tested for use with Chemotherapy Drugs received FDA 510(k) clearance on 2022-05-23, under approval number K220155.

What company makes Powder-free Nitrile Examination Gloves Tested for use with Chemotherapy Drugs?

Powder-free Nitrile Examination Gloves Tested for use with Chemotherapy Drugs is manufactured by Motex Healthcare (Anhui) Co., Ltd..

What is the FDA product code for Powder-free Nitrile Examination Gloves Tested for use with Chemotherapy Drugs?

The FDA product code for Powder-free Nitrile Examination Gloves Tested for use with Chemotherapy Drugs is LZA.

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Related PubMed Literature

PMID: 41398461 Evaluating commercial multimodal AI for diabetic eye screening and implications for an alternative regulatory pathway. NPJ digital medicine (2025)

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 →

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