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FDA 510(k)

Nitrile Patient Examination Gloves

K-Number: K211028 · 2021-06-04

ApplicantHuayuan Medical Technology(Shangqiu) Co., Ltd.
Decision Date2021-06-04
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Nitrile Patient Examination Gloves is a medical device manufactured by Huayuan Medical Technology(Shangqiu) Co., Ltd.. It received FDA 510(k) clearance on 2021-06-04 under approval number K211028. 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?

Nitrile Patient Examination Gloves is a medical device that received FDA 510(k) clearance on 2021-06-04. It is manufactured by Huayuan Medical Technology(Shangqiu) Co., Ltd.. The 510(k) number is K211028.

When was Nitrile Patient Examination Gloves approved by the FDA?

Nitrile Patient Examination Gloves received FDA 510(k) clearance on 2021-06-04, under approval number K211028.

What company makes Nitrile Patient Examination Gloves?

Nitrile Patient Examination Gloves is manufactured by Huayuan Medical Technology(Shangqiu) Co., Ltd..

What is the FDA product code for Nitrile Patient Examination Gloves?

The FDA product code for Nitrile Patient Examination Gloves is LZA.

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

K213048Nitrile Patient Examination Gloves (Tested for Use with Chemotherapy Drugs) K211012Nitrile 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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