Decision Date2016-11-07
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Powder Free Nitrile Examination Gloves (Blue) is a medical device manufactured by Nam Viet Glove Joint Stock Company. It received FDA 510(k) clearance on 2016-11-07 under approval number K162113. 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 Examination Gloves (Blue)?
Powder Free Nitrile Examination Gloves (Blue) is a medical device that received FDA 510(k) clearance on 2016-11-07. It is manufactured by Nam Viet Glove Joint Stock Company. The 510(k) number is K162113.
When was Powder Free Nitrile Examination Gloves (Blue) approved by the FDA?
Powder Free Nitrile Examination Gloves (Blue) received FDA 510(k) clearance on 2016-11-07, under approval number K162113.
What company makes Powder Free Nitrile Examination Gloves (Blue)?
Powder Free Nitrile Examination Gloves (Blue) is manufactured by Nam Viet Glove Joint Stock Company.
What is the FDA product code for Powder Free Nitrile Examination Gloves (Blue)?
The FDA product code for Powder Free Nitrile Examination Gloves (Blue) is LZA.
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Official Source
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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.