FDA 510(k)

Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 Reinforced Surgical Gown

Numéro K : K211422 · 2021-07-02

DemandeurJiangsu Medplus Non-Woven Manufacturer Co., Ltd.

Date de décision2021-07-02

Code produitFYA

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 Reinforced Surgical Gown is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Medplus Non-Woven Manufacturer Co., Ltd.. It received FDA 510(k) clearance on 2021-07-02 under 510(k) number K211422. 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 Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 Reinforced Surgical Gown?

Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 Reinforced Surgical Gown is a medical device that received FDA 510(k) clearance on 2021-07-02. The listed applicant is Jiangsu Medplus Non-Woven Manufacturer Co., Ltd.. The 510(k) number is K211422.

When did Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 Reinforced Surgical Gown receive FDA 510(k) clearance?

Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 Reinforced Surgical Gown received FDA 510(k) clearance on 2021-07-02, under 510(k) number K211422.

Who is the listed applicant for Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 Reinforced Surgical Gown?

The FDA 510(k) record lists Jiangsu Medplus Non-Woven Manufacturer Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 Reinforced Surgical Gown?

The FDA product code for Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 Reinforced Surgical Gown is FYA.

Essais cliniques associés

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Autres dossiers indiquant Jiangsu Medplus Non-Woven Manufacturer Co., Ltd. en tant que demandeur

K202605Standard Procedure Mask, Standard Surgical Mask

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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