FDA 510(k)

HALYARD Flexaprene Green Powder-Free Exam Glove

Numéro K : K211063 · 2021-11-19

Date de décision2021-11-19

Code produitLZA

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

HALYARD Flexaprene Green Powder-Free Exam Glove is the device name listed in this FDA 510(k) record. The listed applicant is O&M Halyard, Inc.. It received FDA 510(k) clearance on 2021-11-19 under 510(k) number K211063. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the HALYARD Flexaprene Green Powder-Free Exam Glove?

HALYARD Flexaprene Green Powder-Free Exam Glove is a medical device that received FDA 510(k) clearance on 2021-11-19. The listed applicant is O&M Halyard, Inc.. The 510(k) number is K211063.

When did HALYARD Flexaprene Green Powder-Free Exam Glove receive FDA 510(k) clearance?

HALYARD Flexaprene Green Powder-Free Exam Glove received FDA 510(k) clearance on 2021-11-19, under 510(k) number K211063.

Who is the listed applicant for HALYARD Flexaprene Green Powder-Free Exam Glove?

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

What is the FDA product code for HALYARD Flexaprene Green Powder-Free Exam Glove?

The FDA product code for HALYARD Flexaprene Green Powder-Free Exam Glove is LZA.

Essais cliniques associés

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Autres dossiers indiquant O&M Halyard, Inc. en tant que demandeur

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Source officielle

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