Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue)
K-Number: K210755 · 2021-05-07
ApplicantMeditech Gloves Sdn Bhd
Decision Date2021-05-07
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue) is a medical device manufactured by Meditech Gloves Sdn Bhd. It received FDA 510(k) clearance on 2021-05-07 under approval number K210755. 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 Gloves, Non-Sterile (Blue)?
Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue) is a medical device that received FDA 510(k) clearance on 2021-05-07. It is manufactured by Meditech Gloves Sdn Bhd. The 510(k) number is K210755.
When was Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue) approved by the FDA?
Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue) received FDA 510(k) clearance on 2021-05-07, under approval number K210755.
What company makes Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue)?
Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue) is manufactured by Meditech Gloves Sdn Bhd.
What is the FDA product code for Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue)?
The FDA product code for Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue) 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.