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FDA 510(k)

Powder-Free Nitrile Examination Glove, Non-Sterile

K-Number: K221877 · 2022-07-23

ApplicantGoodgloves Industries Sdn Bhd
Decision Date2022-07-23
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Powder-Free Nitrile Examination Glove, Non-Sterile is a medical device manufactured by Goodgloves Industries Sdn Bhd. It received FDA 510(k) clearance on 2022-07-23 under approval number K221877. 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 Powder-Free Nitrile Examination Glove, Non-Sterile?

Powder-Free Nitrile Examination Glove, Non-Sterile is a medical device that received FDA 510(k) clearance on 2022-07-23. It is manufactured by Goodgloves Industries Sdn Bhd. The 510(k) number is K221877.

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

Powder-Free Nitrile Examination Glove, Non-Sterile received FDA 510(k) clearance on 2022-07-23, under approval number K221877.

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

Powder-Free Nitrile Examination Glove, Non-Sterile is manufactured by Goodgloves Industries Sdn Bhd.

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

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

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