FDA 510(k)

Procedure mask/Surgical mask/Face mask

Número K: K250082 · 2025-06-18

Data da decisão2025-06-18

Código do produtoFXX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Procedure mask/Surgical mask/Face mask is the device name listed in this FDA 510(k) record. The listed applicant is Winner Medical Co., Ltd.. It received FDA 510(k) clearance on 2025-06-18 under 510(k) number K250082. 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 Procedure mask/Surgical mask/Face mask?

Procedure mask/Surgical mask/Face mask is a medical device that received FDA 510(k) clearance on 2025-06-18. The listed applicant is Winner Medical Co., Ltd.. The 510(k) number is K250082.

When did Procedure mask/Surgical mask/Face mask receive FDA 510(k) clearance?

Procedure mask/Surgical mask/Face mask received FDA 510(k) clearance on 2025-06-18, under 510(k) number K250082.

Who is the listed applicant for Procedure mask/Surgical mask/Face mask?

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

What is the FDA product code for Procedure mask/Surgical mask/Face mask?

The FDA product code for Procedure mask/Surgical mask/Face mask is FXX.

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Outros registros que listam Winner Medical Co., Ltd. como candidato(a)

K252001Collagen Wound Dressing K231057Desinfetante Antibacteriano para Curativo de Ferimento K231564Skin and Wound Cleanser K231152Collagen Wound Dressing K221311Bandagem Antibacteriana K223232Procedure mask/Surgical mask/Face mask

Ver todos os 18 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.

Fonte oficial

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