FDA 510(k)

Medline Level 4 Surgical Gown with Breathable Sleeves

Numéro K : K242844 · 2025-02-26

Date de décision2025-02-26

Code produitFYA

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

Medline Level 4 Surgical Gown with Breathable Sleeves is the device name listed in this FDA 510(k) record. The listed applicant is Medline Industries, LP. It received FDA 510(k) clearance on 2025-02-26 under 510(k) number K242844. The device is classified under product code FYA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Medline Level 4 Surgical Gown with Breathable Sleeves?

Medline Level 4 Surgical Gown with Breathable Sleeves is a medical device that received FDA 510(k) clearance on 2025-02-26. The listed applicant is Medline Industries, LP. The 510(k) number is K242844.

When did Medline Level 4 Surgical Gown with Breathable Sleeves receive FDA 510(k) clearance?

Medline Level 4 Surgical Gown with Breathable Sleeves received FDA 510(k) clearance on 2025-02-26, under 510(k) number K242844.

Who is the listed applicant for Medline Level 4 Surgical Gown with Breathable Sleeves?

The FDA 510(k) record lists Medline Industries, LP as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medline Level 4 Surgical Gown with Breathable Sleeves?

The FDA product code for Medline Level 4 Surgical Gown with Breathable Sleeves is FYA.

Essais cliniques associés

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Dispositifs connexes (Code : FYA)

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Source officielle

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