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FDA 510(k)

Black 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

K-Number: K222294 · 2022-09-24

ApplicantOnetexx Sdn Bhd
Decision Date2022-09-24
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Black 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 is a medical device manufactured by Onetexx Sdn Bhd. It received FDA 510(k) clearance on 2022-09-24 under approval number K222294. 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, Tested for Use With Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl In Gastric Acid?

Black 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 is a medical device that received FDA 510(k) clearance on 2022-09-24. It is manufactured by Onetexx Sdn Bhd. The 510(k) number is K222294.

When was Black 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 approved by the FDA?

Black 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 received FDA 510(k) clearance on 2022-09-24, under approval number K222294.

What company makes Black 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?

Black 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 is manufactured by Onetexx Sdn Bhd.

What is the FDA product code for Black 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?

The FDA product code for Black 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 is LZA.

Related Clinical Trials

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Related PubMed Literature

PMID: 41398461 Evaluating commercial multimodal AI for diabetic eye screening and implications for an alternative regulatory pathway. NPJ digital medicine (2025) PMID: 40854178 Health Professional Students' Knowledge About FDA Drug and Medical Device Regulation. Academic medicine : journal of the Association of American Medical Colleges (2025) PMID: 40069887 Lessons from the National institutes of health innovation corps program: defining barriers to developing and commercializing novel solutions for persons with opioid use disorder. Addiction science & clinical practice (2025)

Other Devices by Onetexx Sdn Bhd

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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.

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