FDA 510(k)

Disposable 4 Layers Surgical Face Mask

Número K: K230093 · 2023-03-02

Data da decisão2023-03-02

Código do produtoFXX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Disposable 4 Layers Surgical Face Mask is the device name listed in this FDA 510(k) record. The listed applicant is Social Medical Supply, LLC. It received FDA 510(k) clearance on 2023-03-02 under 510(k) number K230093. 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 4 Layers Surgical Face Mask?

Disposable 4 Layers Surgical Face Mask is a medical device that received FDA 510(k) clearance on 2023-03-02. The listed applicant is Social Medical Supply, LLC. The 510(k) number is K230093.

When did Disposable 4 Layers Surgical Face Mask receive FDA 510(k) clearance?

Disposable 4 Layers Surgical Face Mask received FDA 510(k) clearance on 2023-03-02, under 510(k) number K230093.

Who is the listed applicant for Disposable 4 Layers Surgical Face Mask?

The FDA 510(k) record lists Social Medical Supply, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable 4 Layers Surgical Face Mask?

The FDA product code for Disposable 4 Layers Surgical Face Mask 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

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.