FDA 510(k)

Black Nitrile Powder Free Patient Examination Glove, Non Sterile

K-Number: K210588 · 2021-10-31

Decision Date2021-10-31

Product CodeLZA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Black Nitrile Powder Free Patient Examination Glove, Non Sterile is a medical device manufactured by Onetexx Sdn Bhd. It received FDA 510(k) clearance on 2021-10-31 under approval number K210588. 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 2021-10-31. It is manufactured by Onetexx Sdn Bhd. The 510(k) number is K210588.

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 2021-10-31, under approval number K210588.

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

Black Nitrile Powder Free Patient Examination Glove, Non Sterile is manufactured by Onetexx 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 Onetexx Sdn Bhd

K210775White Nitrile Powder Free Patient Examination Glove, Non Sterile K210587Violet Nitrile Powder Free Patient Examination Glove, Non Sterile K210366Blue Nitrile Powder Free Patient Examination Glove, Non Sterile K222298Violet Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested for Use With Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl In Gastric Acid K222294Black Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested for Use With Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl In Gastric Acid K221773Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested For Use With the Opioid Fentanyl Citrate, Simulated Gastric Acid, and Fentanyl In Gastric Acid

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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.