Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Orange)
K-Number: K192635 · 2020-01-17
ApplicantWrp Asia Pacific Sdn. Bhd.
Decision Date2020-01-17
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Orange) is a medical device manufactured by Wrp Asia Pacific Sdn. Bhd.. It received FDA 510(k) clearance on 2020-01-17 under approval number K192635. 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 (Orange)?
Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Orange) is a medical device that received FDA 510(k) clearance on 2020-01-17. It is manufactured by Wrp Asia Pacific Sdn. Bhd.. The 510(k) number is K192635.
When was Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Orange) approved by the FDA?
Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Orange) received FDA 510(k) clearance on 2020-01-17, under approval number K192635.
What company makes Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Orange)?
Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Orange) is manufactured by Wrp Asia Pacific Sdn. Bhd..
What is the FDA product code for Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Orange)?
The FDA product code for Powder Free Nitrile Patient Examination Gloves, Non-Sterile (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.