Nitrile Patient Examination gloves, Powderfree, Blue color
K-Number: K143477 · 2016-04-14
ApplicantPrimus Gloves Pvt Limited
Decision Date2016-04-14
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Nitrile Patient Examination gloves, Powderfree, Blue color is a medical device manufactured by Primus Gloves Pvt Limited. It received FDA 510(k) clearance on 2016-04-14 under approval number K143477. 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 Patient Examination gloves, Powderfree, Blue color?
Nitrile Patient Examination gloves, Powderfree, Blue color is a medical device that received FDA 510(k) clearance on 2016-04-14. It is manufactured by Primus Gloves Pvt Limited. The 510(k) number is K143477.
When was Nitrile Patient Examination gloves, Powderfree, Blue color approved by the FDA?
Nitrile Patient Examination gloves, Powderfree, Blue color received FDA 510(k) clearance on 2016-04-14, under approval number K143477.
What company makes Nitrile Patient Examination gloves, Powderfree, Blue color?
Nitrile Patient Examination gloves, Powderfree, Blue color is manufactured by Primus Gloves Pvt Limited.
What is the FDA product code for Nitrile Patient Examination gloves, Powderfree, Blue color?
The FDA product code for Nitrile Patient Examination gloves, Powderfree, Blue color 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.