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FDA 510(k)

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

K-Number: K213048 · 2021-12-18

ApplicantHuayuan Medical Technology(Shangqiu) 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 Huayuan Medical Technology(Shangqiu) Co., Ltd.. It received FDA 510(k) clearance on 2021-12-18 under approval number K213048. 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 Huayuan Medical Technology(Shangqiu) Co., Ltd.. The 510(k) number is K213048.

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 K213048.

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 Huayuan Medical Technology(Shangqiu) 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) PMID: 39707817 Physician-Patient Communication about Novel Drugs and High-Risk Medical Devices. Medical decision making : an international journal of the Society for Medical Decision Making (2025) PMID: 39556835 Information Disclosure, Medical Device Regulation, and Device Safety: The Case of Cook Celect IVC Filters. Annals of internal medicine (2024)

Other Devices by Huayuan Medical Technology(Shangqiu) Co., Ltd.

K211012Nitrile Patient Examination Gloves K211028Nitrile 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

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