FDA 510(k)

Maxima Surgical Gown

Numéro K : K201351 · 2022-03-11

Date de décision2022-03-11

Code produitFYA

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

Maxima Surgical Gown is the device name listed in this FDA 510(k) record. The listed applicant is Elevate Textiles. It received FDA 510(k) clearance on 2022-03-11 under 510(k) number K201351. 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 Maxima Surgical Gown?

Maxima Surgical Gown is a medical device that received FDA 510(k) clearance on 2022-03-11. The listed applicant is Elevate Textiles. The 510(k) number is K201351.

When did Maxima Surgical Gown receive FDA 510(k) clearance?

Maxima Surgical Gown received FDA 510(k) clearance on 2022-03-11, under 510(k) number K201351.

Who is the listed applicant for Maxima Surgical Gown?

The FDA 510(k) record lists Elevate Textiles as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Maxima Surgical Gown?

The FDA product code for Maxima Surgical Gown is FYA.

Essais cliniques associés

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Dispositifs connexes (Code : FYA)

K260407Principle & Will ANSI/AAMI PB 70 (Sterile/Non-sterile) Level 3 Surgical Gowns (Reinforced) and Principle & Will ANSI/AMMI PB70 (Sterile/Non-sterile) Level 4 Surgical Gowns/Isolation GownsPrinciple & Will Co., Ltd.K261028Surgical Gown Level2 (S, M, L, XL, XXL, XXXL)Yadu Medical (Henan) Co., Ltd.K261949NYES Tuff Cuff L3 Disposable GownsNew York Embroidery Studio K252575Tuff Cuff™ Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L)New York Embroidery Studio (NYES)K260725BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10)Hindernis DE Mexico, S.A.P.I. DE C.V.K253243Cardinal Health™ Poly Reinforced Surgical GownCardinal Health 200, LLC

Source officielle

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