FDA 510(k)

ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500

Numéro K : K162442 · 2016-12-12

DemandeurGri Medical & Electrical Technology Co., Ltd.

Date de décision2016-12-12

Code produitFYA

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500 is the device name listed in this FDA 510(k) record. The listed applicant is Gri Medical & Electrical Technology Co., Ltd.. It received FDA 510(k) clearance on 2016-12-12 under 510(k) number K162442. 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 ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500?

ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500 is a medical device that received FDA 510(k) clearance on 2016-12-12. The listed applicant is Gri Medical & Electrical Technology Co., Ltd.. The 510(k) number is K162442.

When did ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500 receive FDA 510(k) clearance?

ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500 received FDA 510(k) clearance on 2016-12-12, under 510(k) number K162442.

Who is the listed applicant for ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500?

The FDA 510(k) record lists Gri Medical & Electrical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500?

The FDA product code for ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500 is FYA.

Essais cliniques associés

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Autres dossiers indiquant Gri Medical & Electrical Technology Co., Ltd. en tant que demandeur

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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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