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FDA 510(k)

Halyard Black-Orange Powder-Free Nitrile Exam Glove

K-Number: K153708 · 2016-03-31

Decision Date2016-03-31
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Halyard Black-Orange Powder-Free Nitrile Exam Glove is the device name listed in this FDA 510(k) record. The listed applicant is Halyard Health. It received FDA 510(k) clearance on 2016-03-31 under 510(k) 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. The listed applicant is Halyard Health. The 510(k) number is K153708.

When did Halyard Black-Orange Powder-Free Nitrile Exam Glove receive FDA 510(k) clearance?

Halyard Black-Orange Powder-Free Nitrile Exam Glove received FDA 510(k) clearance on 2016-03-31, under 510(k) number K153708.

Who is the listed applicant for Halyard Black-Orange Powder-Free Nitrile Exam Glove?

The FDA 510(k) record lists Halyard Health as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Halyard Health as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: LZA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.