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FDA 510(k)

Nitrile disposable examination gloves (Tested for use with Chemotherapy Drugs)

K-Number: K212735 · 2022-01-11

ApplicantXingyu Medical Tech Co., Ltd.
Decision Date2022-01-11
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Nitrile disposable examination gloves (Tested for use with Chemotherapy Drugs) is a medical device manufactured by Xingyu Medical Tech Co., Ltd.. It received FDA 510(k) clearance on 2022-01-11 under approval number K212735. 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 disposable examination gloves (Tested for use with Chemotherapy Drugs)?

Nitrile disposable examination gloves (Tested for use with Chemotherapy Drugs) is a medical device that received FDA 510(k) clearance on 2022-01-11. It is manufactured by Xingyu Medical Tech Co., Ltd.. The 510(k) number is K212735.

When was Nitrile disposable examination gloves (Tested for use with Chemotherapy Drugs) approved by the FDA?

Nitrile disposable examination gloves (Tested for use with Chemotherapy Drugs) received FDA 510(k) clearance on 2022-01-11, under approval number K212735.

What company makes Nitrile disposable examination gloves (Tested for use with Chemotherapy Drugs)?

Nitrile disposable examination gloves (Tested for use with Chemotherapy Drugs) is manufactured by Xingyu Medical Tech Co., Ltd..

What is the FDA product code for Nitrile disposable examination gloves (Tested for use with Chemotherapy Drugs)?

The FDA product code for Nitrile disposable examination gloves (Tested for use with Chemotherapy Drugs) is LZA.

Related Clinical Trials

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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)

Other Devices by Xingyu Medical Tech Co., Ltd.

K212578Nitrile disposable examination gloves K221273Medical Face Mask (M001) K240629Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl

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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