FDA 510(k)

Disposable Surgical Face Mask (3P00B, C2900)

Número K: K252830 · 2026-01-12

RequerenteBeatles Medical Supplies (Xiantao) Co., Ltd.

Data da decisão2026-01-12

Código do produtoFXX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Disposable Surgical Face Mask (3P00B, C2900) is the device name listed in this FDA 510(k) record. The listed applicant is Beatles Medical Supplies (Xiantao) Co., Ltd.. It received FDA 510(k) clearance on 2026-01-12 under 510(k) number K252830. 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 Surgical Face Mask (3P00B, C2900)?

Disposable Surgical Face Mask (3P00B, C2900) is a medical device that received FDA 510(k) clearance on 2026-01-12. The listed applicant is Beatles Medical Supplies (Xiantao) Co., Ltd.. The 510(k) number is K252830.

When did Disposable Surgical Face Mask (3P00B, C2900) receive FDA 510(k) clearance?

Disposable Surgical Face Mask (3P00B, C2900) received FDA 510(k) clearance on 2026-01-12, under 510(k) number K252830.

Who is the listed applicant for Disposable Surgical Face Mask (3P00B, C2900)?

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

What is the FDA product code for Disposable Surgical Face Mask (3P00B, C2900)?

The FDA product code for Disposable Surgical Face Mask (3P00B, C2900) is FXX.

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Dispositivos Relacionados (Código: FXX)

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