FDA 510(k)

PRIMED Surgical and Procedure Masks

N.º K: K252964 · 2025-11-04

SolicitantePrimed Medical Products, Inc.

Fecha de decisión2025-11-04

Código de productoFXX

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

PRIMED Surgical and Procedure Masks is the device name listed in this FDA 510(k) record. The listed applicant is Primed Medical Products, Inc.. It received FDA 510(k) clearance on 2025-11-04 under 510(k) number K252964. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the PRIMED Surgical and Procedure Masks?

PRIMED Surgical and Procedure Masks is a medical device that received FDA 510(k) clearance on 2025-11-04. The listed applicant is Primed Medical Products, Inc.. The 510(k) number is K252964.

When did PRIMED Surgical and Procedure Masks receive FDA 510(k) clearance?

PRIMED Surgical and Procedure Masks received FDA 510(k) clearance on 2025-11-04, under 510(k) number K252964.

Who is the listed applicant for PRIMED Surgical and Procedure Masks?

The FDA 510(k) record lists Primed Medical Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRIMED Surgical and Procedure Masks?

The FDA product code for PRIMED Surgical and Procedure Masks is FXX.

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Otros registros que enlistan a Primed Medical Products, Inc. como solicitante

K262007PRIMED AAMI Level 3 Open Back Gowns K261811PRIMED Chemotherapy Drug Tested Gowns (PM4-99450: PRIMED Chemotherapy Drug Tested Isolation Gown, Purple, AAMI Level 2; PM4-99460: PRIMED Chemotherapy Drug Tested Isolation Gown, Blue, AAMI Level 3)K242208PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)K240286PRIMED Surgical Masks and PRIMED Procedure Masks K233777PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)K213427PRIMED Pediatric Facemask

Ver todos los 8 dispositivos →

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.

Fuente oficial

Ver en la base de datos de la FDA →

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