FDA 510(k)

Disposable Surgical Face Mask (3P00B, C2900)

Номер K: K252830 · 2026-01-12

ЗаявительBeatles Medical Supplies (Xiantao) Co., Ltd.

Дата решения2026-01-12

Код продуктаFXX

Консультативный комитетSU

РешениеSubstantially Equivalent

Описание устройства

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.

Часто задаваемые вопросы

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.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: 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.K252650Disposable Medical Face MaskMakrite Industries, Inc.K243342KP Protective Face MaskKp Trading Co., Ltd.K252941HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* EarloopsO&M Halyard, Inc.

Официальный источник

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