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FDA 510(k)

Violet Nitrile Powder-Free Patient Examination Glove, Non Sterile

K-Number: K220429 · 2022-05-13

ApplicantOne Glove Industrial Sdn Bhd
Decision Date2022-05-13
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Violet 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 2022-05-13 under approval number K220429. 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 Violet Nitrile Powder-Free Patient Examination Glove, Non Sterile?

Violet Nitrile Powder-Free Patient Examination Glove, Non Sterile is a medical device that received FDA 510(k) clearance on 2022-05-13. It is manufactured by One Glove Industrial Sdn Bhd. The 510(k) number is K220429.

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

Violet Nitrile Powder-Free Patient Examination Glove, Non Sterile received FDA 510(k) clearance on 2022-05-13, under approval number K220429.

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

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

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

The FDA product code for Violet 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 K220428Black 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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