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FDA 510(k)

Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free Nitrile Exam Glove

K-Number: K200633 · 2020-10-11

Decision Date2020-10-11
Product CodeLZC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free Nitrile Exam Glove is the device name listed in this FDA 510(k) record. The listed applicant is 0 & M Halyard, Inc.. It received FDA 510(k) clearance on 2020-10-11 under 510(k) number K200633. The device is classified under product code LZC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free Nitrile Exam Glove?

Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free Nitrile Exam Glove is a medical device that received FDA 510(k) clearance on 2020-10-11. The listed applicant is 0 & M Halyard, Inc.. The 510(k) number is K200633.

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

Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free Nitrile Exam Glove received FDA 510(k) clearance on 2020-10-11, under 510(k) number K200633.

Who is the listed applicant for Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free Nitrile Exam Glove?

The FDA 510(k) record lists 0 & M Halyard, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free Nitrile Exam Glove?

The FDA product code for Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free Nitrile Exam Glove is LZC.

Related Devices (Code: LZC)

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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