FDA 510(k)

Nitrile Powder Free Examination Gloves, Non-Sterile - Blue, Black, Orange

K-Number: K220232 · 2022-02-20

Decision Date2022-02-20

Product CodeLZA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Nitrile Powder Free Examination Gloves, Non-Sterile - Blue, Black, Orange is the device name listed in this FDA 510(k) record. The listed applicant is Megine Industries Sdn Bhd. It received FDA 510(k) clearance on 2022-02-20 under 510(k) number K220232. 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 Nitrile Powder Free Examination Gloves, Non-Sterile - Blue, Black, Orange?

Nitrile Powder Free Examination Gloves, Non-Sterile - Blue, Black, Orange is a medical device that received FDA 510(k) clearance on 2022-02-20. The listed applicant is Megine Industries Sdn Bhd. The 510(k) number is K220232.

When did Nitrile Powder Free Examination Gloves, Non-Sterile - Blue, Black, Orange receive FDA 510(k) clearance?

Nitrile Powder Free Examination Gloves, Non-Sterile - Blue, Black, Orange received FDA 510(k) clearance on 2022-02-20, under 510(k) number K220232.

Who is the listed applicant for Nitrile Powder Free Examination Gloves, Non-Sterile - Blue, Black, Orange?

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

What is the FDA product code for Nitrile Powder Free Examination Gloves, Non-Sterile - Blue, Black, Orange?

The FDA product code for Nitrile Powder Free Examination Gloves, Non-Sterile - Blue, Black, Orange is LZA.

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Other records listing Megine Industries Sdn Bhd as applicant

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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.