FDA 510(k)

Disposable medical surgical mask

N.º K: K212097 · 2021-08-18

SolicitanteHebei Titans Hongsen Medical Technology Co., Ltd.

Fecha de decisión2021-08-18

Código de productoFXX

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Disposable medical surgical mask is the device name listed in this FDA 510(k) record. The listed applicant is Hebei Titans Hongsen Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-08-18 under 510(k) number K212097. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Disposable medical surgical mask?

Disposable medical surgical mask is a medical device that received FDA 510(k) clearance on 2021-08-18. The listed applicant is Hebei Titans Hongsen Medical Technology Co., Ltd.. The 510(k) number is K212097.

When did Disposable medical surgical mask receive FDA 510(k) clearance?

Disposable medical surgical mask received FDA 510(k) clearance on 2021-08-18, under 510(k) number K212097.

Who is the listed applicant for Disposable medical surgical mask?

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

What is the FDA product code for Disposable medical surgical mask?

The FDA product code for Disposable medical surgical mask is FXX.

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 Hebei Titans Hongsen Medical Technology Co., Ltd. como solicitante

K240361Powder Free Green Nitrile Examination Gloves (XS/S/M/L/XL); Powder Free Pink Nitrile Examination Gloves (XS/S/M/L/XL); Powder Free Purple Nitrile Examination Gloves (XS/S/M/L/XL)K223895Disposable Medical Nitrile Examination Gloves K221374Disposable Medical Rubber Examination Gloves (XS/S/M/L/XL)K211229Vinyl compound examination gloves K182043Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored)K181130Powder Free Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs

Ver todos los 7 dispositivos →

Dispositivos relacionados (Código: FXX)

K251967HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround VisorO&M Halyard, Inc.K252534Surgical Face Mask (Ear mount)Zhejiang Hangkang Medical Equipment Co., Ltd.K253398Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)Efofex, Inc.K252830Disposable Surgical Face Mask (3P00B, C2900)Beatles Medical Supplies (Xiantao) Co., Ltd.K252650Disposable Medical Face MaskMakrite Industries, Inc.K243342KP Protective Face MaskKp Trading Co., Ltd.

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.