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FDA 510(k)

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

K-Number: K213051 · 2021-12-18

ApplicantYunnan Huazhiyuan Medical Technology Co., Ltd.
Decision Date2021-12-18
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Nitrile Patient Examination Gloves (Tested for Use with Chemotherapy Drugs) is a medical device manufactured by Yunnan Huazhiyuan Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-12-18 under approval number K213051. 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 Patient Examination Gloves (Tested for Use with Chemotherapy Drugs)?

Nitrile Patient Examination Gloves (Tested for Use with Chemotherapy Drugs) is a medical device that received FDA 510(k) clearance on 2021-12-18. It is manufactured by Yunnan Huazhiyuan Medical Technology Co., Ltd.. The 510(k) number is K213051.

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

Nitrile Patient Examination Gloves (Tested for Use with Chemotherapy Drugs) received FDA 510(k) clearance on 2021-12-18, under approval number K213051.

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

Nitrile Patient Examination Gloves (Tested for Use with Chemotherapy Drugs) is manufactured by Yunnan Huazhiyuan Medical Technology Co., Ltd..

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

The FDA product code for Nitrile Patient 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) PMID: 40854178 Health Professional Students' Knowledge About FDA Drug and Medical Device Regulation. Academic medicine : journal of the Association of American Medical Colleges (2025)

Other Devices by Yunnan Huazhiyuan Medical Technology Co., Ltd.

K212002Synthetic Vinyl Examination Gloves K210686Nitrile Patient Examination Glove K210799Powder Free Vinyl Patient Examination Gloves

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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