FDA 510(k)

Disposable Surgical Gown

Numéro K : K212925 · 2021-12-13

DemandeurHenan Robestain Medical Products Co., Ltd.

Date de décision2021-12-13

Code produitFYA

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

Disposable Surgical Gown is the device name listed in this FDA 510(k) record. The listed applicant is Henan Robestain Medical Products Co., Ltd.. It received FDA 510(k) clearance on 2021-12-13 under 510(k) number K212925. 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 Disposable Surgical Gown?

Disposable Surgical Gown is a medical device that received FDA 510(k) clearance on 2021-12-13. The listed applicant is Henan Robestain Medical Products Co., Ltd.. The 510(k) number is K212925.

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

Disposable Surgical Gown received FDA 510(k) clearance on 2021-12-13, under 510(k) number K212925.

Who is the listed applicant for Disposable Surgical Gown?

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

What is the FDA product code for Disposable Surgical Gown?

The FDA product code for Disposable Surgical Gown is FYA.

Essais cliniques associés

Les enregistrements connexes sont mis en correspondance automatiquement à l'aide des noms, codes produits ou autres métadonnées. Une mise en correspondance n'établit pas de relation clinique, scientifique, corporative ou réglementaire vérifiée ; veuillez consulter les sources officielles liées.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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

Voir dans la base de données FDA →

Données issues de l'API ouverte de la FDA. Pour les informations les plus récentes et faisant autorité, veuillez toujours vous référer au registre officiel.