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FDA 510(k)

Disposable Nitrile Examination Glove(Tested for use with Chemotherapy Drug)

K-Number: K222642 · 2022-09-20

ApplicantInner Mongolia Cureguard Medical Technology Co., Ltd.
Decision Date2022-09-20
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Disposable Nitrile Examination Glove(Tested for use with Chemotherapy Drug) is a medical device manufactured by Inner Mongolia Cureguard Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-09-20 under approval number K222642. 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 Examination Glove(Tested for use with Chemotherapy Drug)?

Disposable Nitrile Examination Glove(Tested for use with Chemotherapy Drug) is a medical device that received FDA 510(k) clearance on 2022-09-20. It is manufactured by Inner Mongolia Cureguard Medical Technology Co., Ltd.. The 510(k) number is K222642.

When was Disposable Nitrile Examination Glove(Tested for use with Chemotherapy Drug) approved by the FDA?

Disposable Nitrile Examination Glove(Tested for use with Chemotherapy Drug) received FDA 510(k) clearance on 2022-09-20, under approval number K222642.

What company makes Disposable Nitrile Examination Glove(Tested for use with Chemotherapy Drug)?

Disposable Nitrile Examination Glove(Tested for use with Chemotherapy Drug) is manufactured by Inner Mongolia Cureguard Medical Technology Co., Ltd..

What is the FDA product code for Disposable Nitrile Examination Glove(Tested for use with Chemotherapy Drug)?

The FDA product code for Disposable Nitrile Examination Glove(Tested for use with Chemotherapy Drug) 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 Inner Mongolia Cureguard Medical Technology Co., Ltd.

K212661Disposable Nitrile Examination Glove K212401Disposable Nitrile Examination 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

View on FDA Database →

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

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