Nitrile Powder Free Examination Gloves, Non-Sterile - Blue, Black, Orange
K-Number: K220232 · 2022-02-20
ApplicantMegine Industries Sdn Bhd
Decision Date2022-02-20
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Nitrile Powder Free Examination Gloves, Non-Sterile - Blue, Black, Orange is a medical device manufactured by Megine Industries Sdn Bhd. It received FDA 510(k) clearance on 2022-02-20 under approval 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. It is manufactured by Megine Industries Sdn Bhd. The 510(k) number is K220232.
When was Nitrile Powder Free Examination Gloves, Non-Sterile - Blue, Black, Orange approved by the FDA?
Nitrile Powder Free Examination Gloves, Non-Sterile - Blue, Black, Orange received FDA 510(k) clearance on 2022-02-20, under approval number K220232.
What company makes Nitrile Powder Free Examination Gloves, Non-Sterile - Blue, Black, Orange?
Nitrile Powder Free Examination Gloves, Non-Sterile - Blue, Black, Orange is manufactured by Megine Industries Sdn Bhd.
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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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.