FDA 510(k)

Chaleco de Aislamiento Desechable - Nivel 3, Grande, Azul, Chaleco de Aislamiento Desechable - Nivel 3, Extra Grande, Azul

N.º K: K212633 · 2021-11-24

Fecha de decisión2021-11-24

Código de productoFYC

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Disposable Isolation Gown -Level 3, Large, Blue, Disposable Isolation Gown - Level 3, X-Large, Blue is the device name listed in this FDA 510(k) record. The listed applicant is String King Lacrosse, LLC. It received FDA 510(k) clearance on 2021-11-24 under 510(k) number K212633. The device is classified under product code FYC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Disposable Isolation Gown -Level 3, Large, Blue, Disposable Isolation Gown - Level 3, X-Large, Blue?

Disposable Isolation Gown -Level 3, Large, Blue, Disposable Isolation Gown - Level 3, X-Large, Blue is a medical device that received FDA 510(k) clearance on 2021-11-24. The listed applicant is String King Lacrosse, LLC. The 510(k) number is K212633.

When did Disposable Isolation Gown -Level 3, Large, Blue, Disposable Isolation Gown - Level 3, X-Large, Blue receive FDA 510(k) clearance?

Disposable Isolation Gown -Level 3, Large, Blue, Disposable Isolation Gown - Level 3, X-Large, Blue received FDA 510(k) clearance on 2021-11-24, under 510(k) number K212633.

Who is the listed applicant for Disposable Isolation Gown -Level 3, Large, Blue, Disposable Isolation Gown - Level 3, X-Large, Blue?

The FDA 510(k) record lists String King Lacrosse, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Isolation Gown -Level 3, Large, Blue, Disposable Isolation Gown - Level 3, X-Large, Blue?

The FDA product code for Disposable Isolation Gown -Level 3, Large, Blue, Disposable Isolation Gown - Level 3, X-Large, Blue is FYC.

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 NCT07095751Sistema de Evaluación de Catéter Uro-Cam Asistido por Inteligencia Artificial para el Diagnóstico de Cáncer de VésículaNOT_YET_RECRUITING

Otros registros que enlistan a String King Lacrosse, LLC como solicitante

K202607Surgical Mask - Level 3 - Blue - 50 pcs, Surgical Mask - Level 3 - White - 50 pcs, Procedure Mask - Level 3 - Blue - 50 pcs, Procedure Mask - Level 3 - White - 50 pcs

Dispositivos relacionados (Código: FYC)

K232849Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMI 3 Isolation Gown, X-Large, Blue (54311)Owens & Minor (O&M) Halyard, Inc.K230135Copioumed Chaleco de Aislamiento de QuimioterapiaCopioumed International, Inc.K223467Chaleco de Aislamiento DesechableNanning Tecbod Biological Technology Co., Ltd.K223304Chalecos de Aislamiento Desechables (S, M, L, XL, XXL, XXXL)Xiamen Probtain Medical Technology Co., Ltd.K223411Chalecos de Aislamiento Desechables (S, M, L, XL, XXL, XXXL)Xiamen Probtain Medical Techology Co., Ltd.K212717Paneffort AAMI Level 3 Isolation GownPaneffort, 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.