FDA 510(k)

High Protection Surgical Gown

N.º K: K222456 · 2023-03-12

Solicitante3A Medical Products Co., Ltd.

Fecha de decisión2023-03-12

Código de productoFYA

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

High Protection Surgical Gown is the device name listed in this FDA 510(k) record. The listed applicant is 3A Medical Products Co., Ltd.. It received FDA 510(k) clearance on 2023-03-12 under 510(k) number K222456. The device is classified under product code FYA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the High Protection Surgical Gown?

High Protection Surgical Gown is a medical device that received FDA 510(k) clearance on 2023-03-12. The listed applicant is 3A Medical Products Co., Ltd.. The 510(k) number is K222456.

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

High Protection Surgical Gown received FDA 510(k) clearance on 2023-03-12, under 510(k) number K222456.

Who is the listed applicant for High Protection Surgical Gown?

The FDA 510(k) record lists 3A Medical Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for High Protection Surgical Gown?

The FDA product code for High Protection Surgical Gown is FYA.

Ensayos clínicos relacionados

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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

Otros registros que enlistan a 3A Medical Products Co., Ltd. como solicitante

K202598Mascarilla quirúrgica de 3 capas con Aretes Nivel 1, Mascarilla quirúrgica de 3 capas con Cordones Nivel 1, Mascarilla quirúrgica de 3 capas con Aretes Nivel 2, Mascarilla quirúrgica de 3 capas con Cordones Nivel 2, Mascarilla quirúrgica de 3 capas con Aretes Nivel 3, Mascarilla quirúrgica de 3 capas con Cordones Nivel 3

Dispositivos relacionados (Código: 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

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.