FDA 510(k)

White Nitrile Powder-Free Patient Examination Glove, Non Sterile

K-Number: K220427 · 2022-05-10

Decision Date2022-05-10

Product CodeLZA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

White 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 K220427. 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 White Nitrile Powder-Free Patient Examination Glove, Non Sterile?

White 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 K220427.

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

White Nitrile Powder-Free Patient Examination Glove, Non Sterile received FDA 510(k) clearance on 2022-05-10, under approval number K220427.

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

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

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

The FDA product code for White 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 K220428Black Nitrile Powder-Free Patient Examination Glove, Non-Sterile

Related Devices (Code: LZA)

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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.