Black Nitrile Powder Free Patient Examination Glove, Non Sterile
K-Number: K212916 · 2022-03-24
ApplicantRimba Glove Sdn Bhd
Decision Date2022-03-24
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Black Nitrile Powder Free Patient Examination Glove, Non Sterile is a medical device manufactured by Rimba Glove Sdn Bhd. It received FDA 510(k) clearance on 2022-03-24 under approval number K212916. 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 Black Nitrile Powder Free Patient Examination Glove, Non Sterile?
Black Nitrile Powder Free Patient Examination Glove, Non Sterile is a medical device that received FDA 510(k) clearance on 2022-03-24. It is manufactured by Rimba Glove Sdn Bhd. The 510(k) number is K212916.
When was Black Nitrile Powder Free Patient Examination Glove, Non Sterile approved by the FDA?
Black Nitrile Powder Free Patient Examination Glove, Non Sterile received FDA 510(k) clearance on 2022-03-24, under approval number K212916.
What company makes Black Nitrile Powder Free Patient Examination Glove, Non Sterile?
Black Nitrile Powder Free Patient Examination Glove, Non Sterile is manufactured by Rimba Glove Sdn Bhd.
What is the FDA product code for Black Nitrile Powder Free Patient Examination Glove, Non Sterile?
The FDA product code for Black Nitrile Powder Free Patient Examination Glove, Non Sterile 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.