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FDA 510(k)

Nitrile Glove Powder Free Blue

K-Number: K210145 · 2021-04-21

ApplicantChangzhou Universal Medical Equipment Co., Ltd.
Decision Date2021-04-21
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Nitrile Glove Powder Free Blue is a medical device manufactured by Changzhou Universal Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2021-04-21 under approval number K210145. 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 Glove Powder Free Blue?

Nitrile Glove Powder Free Blue is a medical device that received FDA 510(k) clearance on 2021-04-21. It is manufactured by Changzhou Universal Medical Equipment Co., Ltd.. The 510(k) number is K210145.

When was Nitrile Glove Powder Free Blue approved by the FDA?

Nitrile Glove Powder Free Blue received FDA 510(k) clearance on 2021-04-21, under approval number K210145.

What company makes Nitrile Glove Powder Free Blue?

Nitrile Glove Powder Free Blue is manufactured by Changzhou Universal Medical Equipment Co., Ltd..

What is the FDA product code for Nitrile Glove Powder Free Blue?

The FDA product code for Nitrile Glove Powder Free Blue is LZA.

Other Devices by Changzhou Universal Medical Equipment Co., Ltd.

K211667Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile) K213910Disposable Medical Nitrile Examination Gloves- Tested for Use with Chemotherapy Drugs

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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