FDA 510(k)

Disposable Medical Face Mask (DF3-001)

Número K: K222697 · 2022-11-04

RequerenteWellmed Dental Medical Supply Co., Ltd.

Data da decisão2022-11-04

Código do produtoFXX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Disposable Medical Face Mask (DF3-001) is the device name listed in this FDA 510(k) record. The listed applicant is Wellmed Dental Medical Supply Co., Ltd.. It received FDA 510(k) clearance on 2022-11-04 under 510(k) number K222697. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Disposable Medical Face Mask (DF3-001)?

Disposable Medical Face Mask (DF3-001) is a medical device that received FDA 510(k) clearance on 2022-11-04. The listed applicant is Wellmed Dental Medical Supply Co., Ltd.. The 510(k) number is K222697.

When did Disposable Medical Face Mask (DF3-001) receive FDA 510(k) clearance?

Disposable Medical Face Mask (DF3-001) received FDA 510(k) clearance on 2022-11-04, under 510(k) number K222697.

Who is the listed applicant for Disposable Medical Face Mask (DF3-001)?

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

What is the FDA product code for Disposable Medical Face Mask (DF3-001)?

The FDA product code for Disposable Medical Face Mask (DF3-001) is FXX.

Ensaios clínicos relacionados

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

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

Outros registros que listam Wellmed Dental Medical Supply Co., Ltd. como candidato(a)

K243721Self Sealing Sterilization Pouches K242435Dental Barrier and Sleeves

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.

Fonte oficial

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.