FDA 510(k)

Standard Surgical Gown (AAMI Level 2); Reinforced Surgical Gown (AAMI Level 2)

K-Nummer: K222480 · 2022-11-14

AntragstellerFoshan Nanhai Plus Medical Co, Ltd.

Entscheidungsdatum2022-11-14

ProduktcodeFYA

BeratungsausschussSU

EntscheidungSubstantially Equivalent

Produktübersicht

Standard Surgical Gown (AAMI Level 2); Reinforced Surgical Gown (AAMI Level 2) is the device name listed in this FDA 510(k) record. The listed applicant is Foshan Nanhai Plus Medical Co, Ltd.. It received FDA 510(k) clearance on 2022-11-14 under 510(k) number K222480. The device is classified under product code FYA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the Standard Surgical Gown (AAMI Level 2); Reinforced Surgical Gown (AAMI Level 2)?

Standard Surgical Gown (AAMI Level 2); Reinforced Surgical Gown (AAMI Level 2) is a medical device that received FDA 510(k) clearance on 2022-11-14. The listed applicant is Foshan Nanhai Plus Medical Co, Ltd.. The 510(k) number is K222480.

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

Standard Surgical Gown (AAMI Level 2); Reinforced Surgical Gown (AAMI Level 2) received FDA 510(k) clearance on 2022-11-14, under 510(k) number K222480.

Who is the listed applicant for Standard Surgical Gown (AAMI Level 2); Reinforced Surgical Gown (AAMI Level 2)?

The FDA 510(k) record lists Foshan Nanhai Plus Medical Co, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Standard Surgical Gown (AAMI Level 2); Reinforced Surgical Gown (AAMI Level 2)?

The FDA product code for Standard Surgical Gown (AAMI Level 2); Reinforced Surgical Gown (AAMI Level 2) is FYA.

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Weitere Einträge mit Foshan Nanhai Plus Medical Co, Ltd. als Antragsteller

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Verwandte Geräte (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

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