FDA 510(k)

NYES Tuff Cuff L3 Disposable Gowns

Numéro K : K261949 · 2026-07-10

Date de décision2026-07-10

Code produitFYA

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

NYES Tuff Cuff L3 Disposable Gowns is the device name listed in this FDA 510(k) record. The listed applicant is New York Embroidery Studio. It received FDA 510(k) clearance on 2026-07-10 under 510(k) number K261949. 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 NYES Tuff Cuff L3 Disposable Gowns?

NYES Tuff Cuff L3 Disposable Gowns is a medical device that received FDA 510(k) clearance on 2026-07-10. The listed applicant is New York Embroidery Studio. The 510(k) number is K261949.

When did NYES Tuff Cuff L3 Disposable Gowns receive FDA 510(k) clearance?

NYES Tuff Cuff L3 Disposable Gowns received FDA 510(k) clearance on 2026-07-10, under 510(k) number K261949.

Who is the listed applicant for NYES Tuff Cuff L3 Disposable Gowns?

The FDA 510(k) record lists New York Embroidery Studio as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NYES Tuff Cuff L3 Disposable Gowns?

The FDA product code for NYES Tuff Cuff L3 Disposable Gowns 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.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 K253003Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown (M4025); Non-sterile Reinforced Level 4 Surgical Gown (G4025); Reinforced Sterile Level 4 Surgical Gown (GM4025)Hubei Xinxin Non-Woven Co., Ltd.

Source officielle

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