FDA 510(k)

Surgical Face Mask (Ear mount)

Номер K: K252534 · 2026-03-03

ЗаявительZhejiang Hangkang Medical Equipment Co., Ltd.

Дата решения2026-03-03

Код продуктаFXX

Консультативный комитетSU

РешениеSubstantially Equivalent

Описание устройства

Surgical Face Mask (Ear mount) is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Hangkang Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2026-03-03 under 510(k) number K252534. 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 Surgical Face Mask (Ear mount)?

Surgical Face Mask (Ear mount) is a medical device that received FDA 510(k) clearance on 2026-03-03. The listed applicant is Zhejiang Hangkang Medical Equipment Co., Ltd.. The 510(k) number is K252534.

When did Surgical Face Mask (Ear mount) receive FDA 510(k) clearance?

Surgical Face Mask (Ear mount) received FDA 510(k) clearance on 2026-03-03, under 510(k) number K252534.

Who is the listed applicant for Surgical Face Mask (Ear mount)?

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

What is the FDA product code for Surgical Face Mask (Ear mount)?

The FDA product code for Surgical Face Mask (Ear mount) 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.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.K252941HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* EarloopsO&M Halyard, Inc.

Официальный источник

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