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FDA 510(k)

Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Mask

Número K: K202595 · 2021-01-21

RequerentePremier Guard USA, LLC
Data da decisão2021-01-21
Código do produtoFXX
Comité consultivoSU
DecisãoSubstantially Equivalent

Resumo do dispositivo

Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Mask is the device name listed in this FDA 510(k) record. The listed applicant is Premier Guard USA, LLC. It received FDA 510(k) clearance on 2021-01-21 under 510(k) number K202595. 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 Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Mask?

Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Mask is a medical device that received FDA 510(k) clearance on 2021-01-21. The listed applicant is Premier Guard USA, LLC. The 510(k) number is K202595.

When did Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Mask receive FDA 510(k) clearance?

Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Mask received FDA 510(k) clearance on 2021-01-21, under 510(k) number K202595.

Who is the listed applicant for Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Mask?

The FDA 510(k) record lists Premier Guard USA, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Mask?

The FDA product code for Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Mask is FXX.

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Dispositivos Relacionados (Código: FXX)

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.

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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