FDA 510(k)

Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMI 3 Isolation Gown, X-Large, Blue (54311)

Numéro K : K232849 · 2024-05-16

DemandeurOwens & Minor (O&M) Halyard, Inc.

Date de décision2024-05-16

Code produitFYC

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMI 3 Isolation Gown, X-Large, Blue (54311) is the device name listed in this FDA 510(k) record. The listed applicant is Owens & Minor (O&M) Halyard, Inc.. It received FDA 510(k) clearance on 2024-05-16 under 510(k) number K232849. The device is classified under product code FYC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMI 3 Isolation Gown, X-Large, Blue (54311)?

Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMI 3 Isolation Gown, X-Large, Blue (54311) is a medical device that received FDA 510(k) clearance on 2024-05-16. The listed applicant is Owens & Minor (O&M) Halyard, Inc.. The 510(k) number is K232849.

When did Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMI 3 Isolation Gown, X-Large, Blue (54311) receive FDA 510(k) clearance?

Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMI 3 Isolation Gown, X-Large, Blue (54311) received FDA 510(k) clearance on 2024-05-16, under 510(k) number K232849.

Who is the listed applicant for Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMI 3 Isolation Gown, X-Large, Blue (54311)?

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

What is the FDA product code for Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMI 3 Isolation Gown, X-Large, Blue (54311)?

The FDA product code for Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMI 3 Isolation Gown, X-Large, Blue (54311) is FYC.

Essais cliniques associés

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Source officielle

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