Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile
K-Number: K190606 · 2019-05-28
ApplicantKossan International Sdn Bhd
Decision Date2019-05-28
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile is a medical device manufactured by Kossan International Sdn Bhd. It received FDA 510(k) clearance on 2019-05-28 under approval number K190606. 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 Patient Examination Glove, Black Colored, Non-Sterile?
Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile is a medical device that received FDA 510(k) clearance on 2019-05-28. It is manufactured by Kossan International Sdn Bhd. The 510(k) number is K190606.
When was Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile approved by the FDA?
Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile received FDA 510(k) clearance on 2019-05-28, under approval number K190606.
What company makes Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile?
Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile is manufactured by Kossan International Sdn Bhd.
What is the FDA product code for Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile?
The FDA product code for Powder Free Nitrile Patient Examination Glove, Black Colored, 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.