Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)
K-Number: K162646 · 2017-03-03
ApplicantHartalega NGC Sdn. Bhd.
Decision Date2017-03-03
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue) is a medical device manufactured by Hartalega NGC Sdn. Bhd.. It received FDA 510(k) clearance on 2017-03-03 under approval number K162646. 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 Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)?
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue) is a medical device that received FDA 510(k) clearance on 2017-03-03. It is manufactured by Hartalega NGC Sdn. Bhd.. The 510(k) number is K162646.
When was Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue) approved by the FDA?
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue) received FDA 510(k) clearance on 2017-03-03, under approval number K162646.
What company makes Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)?
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue) is manufactured by Hartalega NGC Sdn. Bhd..
What is the FDA product code for Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)?
The FDA product code for Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (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.