FDA 510(k)

Procedure Mask with Ear Loops and Surgical Mask with Ties

Número K: K221134 · 2022-05-19

Data da decisão2022-05-19

Código do produtoFXX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Procedure Mask with Ear Loops and Surgical Mask with Ties is the device name listed in this FDA 510(k) record. The listed applicant is Safesource Direct, LLC. It received FDA 510(k) clearance on 2022-05-19 under 510(k) number K221134. 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 with Ear Loops and Surgical Mask with Ties?

Procedure Mask with Ear Loops and Surgical Mask with Ties is a medical device that received FDA 510(k) clearance on 2022-05-19. The listed applicant is Safesource Direct, LLC. The 510(k) number is K221134.

When did Procedure Mask with Ear Loops and Surgical Mask with Ties receive FDA 510(k) clearance?

Procedure Mask with Ear Loops and Surgical Mask with Ties received FDA 510(k) clearance on 2022-05-19, under 510(k) number K221134.

Who is the listed applicant for Procedure Mask with Ear Loops and Surgical Mask with Ties?

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

What is the FDA product code for Procedure Mask with Ear Loops and Surgical Mask with Ties?

The FDA product code for Procedure Mask with Ear Loops and Surgical Mask with Ties is FXX.

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Outros registros que listam Safesource Direct, LLC como candidato(a)

K250502SafeSource Direct Blue Powder-Free Nitrile Exam Gloves (AMERI-TUFF Series 4000, AMERI-TOUCH Series 5000)K222898SafeSource Direct Blue Powder-Free Nitrile Exam Gloves

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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