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FDA 510(k)

Black Nitrile Powder-Free Patient Examination Glove, Non-Sterile

K-Number: K220428 · 2022-05-10

ApplicantOne Glove Industrial Sdn Bhd
Decision Date2022-05-10
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Black Nitrile Powder-Free Patient Examination Glove, Non-Sterile is a medical device manufactured by One Glove Industrial Sdn Bhd. It received FDA 510(k) clearance on 2022-05-10 under approval number K220428. 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 Black Nitrile Powder-Free Patient Examination Glove, Non-Sterile?

Black Nitrile Powder-Free Patient Examination Glove, Non-Sterile is a medical device that received FDA 510(k) clearance on 2022-05-10. It is manufactured by One Glove Industrial Sdn Bhd. The 510(k) number is K220428.

When was Black Nitrile Powder-Free Patient Examination Glove, Non-Sterile approved by the FDA?

Black Nitrile Powder-Free Patient Examination Glove, Non-Sterile received FDA 510(k) clearance on 2022-05-10, under approval number K220428.

What company makes Black Nitrile Powder-Free Patient Examination Glove, Non-Sterile?

Black Nitrile Powder-Free Patient Examination Glove, Non-Sterile is manufactured by One Glove Industrial Sdn Bhd.

What is the FDA product code for Black Nitrile Powder-Free Patient Examination Glove, Non-Sterile?

The FDA product code for Black Nitrile Powder-Free Patient Examination Glove, Non-Sterile is LZA.

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Other Devices by One Glove Industrial Sdn Bhd

K220431Blue Nitrile Powder-Free Patient Examination Glove, Non-Sterile K220429Violet Nitrile Powder-Free Patient Examination Glove, Non Sterile K220427White Nitrile Powder-Free Patient Examination Glove, Non Sterile

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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