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FDA 510(k)

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

K-Number: K212919 · 2021-12-15

ApplicantJiujiang Taixin Technology Co., Ltd.
Decision Date2021-12-15
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Disposable Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) is a medical device manufactured by Jiujiang Taixin Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-12-15 under approval number K212919. 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 Gloves (Tested for Use with Chemotherapy Drugs)?

Disposable Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) is a medical device that received FDA 510(k) clearance on 2021-12-15. It is manufactured by Jiujiang Taixin Technology Co., Ltd.. The 510(k) number is K212919.

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

Disposable Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) received FDA 510(k) clearance on 2021-12-15, under approval number K212919.

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

Disposable Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) is manufactured by Jiujiang Taixin Technology Co., Ltd..

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

The FDA product code for Disposable 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)

Other Devices by Jiujiang Taixin Technology Co., Ltd.

K220191Disposable Face Mask

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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