FDA 510(k)

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

Numéro K : K200633 · 2020-10-11

Date de décision2020-10-11

Code produitLZC

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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.

Essais cliniques associés

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Dispositifs connexes (Code : LZC)

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Source officielle

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