FDA 510(k)

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

K-Number: K220431 · 2022-06-17

Decision Date2022-06-17

Product CodeLZA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Blue Nitrile Powder-Free Patient Examination Glove, Non-Sterile is the device name listed in this FDA 510(k) record. The listed applicant is One Glove Industrial Sdn Bhd. It received FDA 510(k) clearance on 2022-06-17 under 510(k) number K220431. 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 Blue Nitrile Powder-Free Patient Examination Glove, Non-Sterile?

Blue Nitrile Powder-Free Patient Examination Glove, Non-Sterile is a medical device that received FDA 510(k) clearance on 2022-06-17. The listed applicant is One Glove Industrial Sdn Bhd. The 510(k) number is K220431.

When did Blue Nitrile Powder-Free Patient Examination Glove, Non-Sterile receive FDA 510(k) clearance?

Blue Nitrile Powder-Free Patient Examination Glove, Non-Sterile received FDA 510(k) clearance on 2022-06-17, under 510(k) number K220431.

Who is the listed applicant for Blue Nitrile Powder-Free Patient Examination Glove, Non-Sterile?

The FDA 510(k) record lists One Glove Industrial Sdn Bhd as the applicant. This does not by itself establish the device manufacturer.

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

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

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Other records listing One Glove Industrial Sdn Bhd as applicant

K220429Violet 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)

K262014PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam GlovesO&M Halyard, Inc.K254285Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Aqua Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Violet Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Dark Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Dark Violet BlueHartalega NGC Sdn. Bhd.K252117Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate-Simulated Gastric Acid SolutionSw Technologies, Inc.K253824Powder Free Nitrile Examination Gloves Non-Sterile BlackKanglongda Vietnam Protection Technology Company Limited K260867Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black)Hartalega NGC Sdn. Bhd.K260806Nitrile Disposable Examination GlovesVista Industries,, LLC

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.