Halyard Black-Orange Powder-Free Nitrile Exam Glove
K-Number: K153708 · 2016-03-31
ApplicantHalyard Health
Decision Date2016-03-31
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Halyard Black-Orange Powder-Free Nitrile Exam Glove is a medical device manufactured by Halyard Health. It received FDA 510(k) clearance on 2016-03-31 under approval number K153708. 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 Halyard Black-Orange Powder-Free Nitrile Exam Glove?
Halyard Black-Orange Powder-Free Nitrile Exam Glove is a medical device that received FDA 510(k) clearance on 2016-03-31. It is manufactured by Halyard Health. The 510(k) number is K153708.
When was Halyard Black-Orange Powder-Free Nitrile Exam Glove approved by the FDA?
Halyard Black-Orange Powder-Free Nitrile Exam Glove received FDA 510(k) clearance on 2016-03-31, under approval number K153708.
What company makes Halyard Black-Orange Powder-Free Nitrile Exam Glove?
Halyard Black-Orange Powder-Free Nitrile Exam Glove is manufactured by Halyard Health.
What is the FDA product code for Halyard Black-Orange Powder-Free Nitrile Exam Glove?
The FDA product code for Halyard Black-Orange Powder-Free Nitrile Exam Glove 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.