FDA 510(k)

PRIMED AAMI Level 3 Open Back Gowns

N.º K: K262007 · 2026-09-11

SolicitantePRIMED Medical Products, Inc.

Fecha de decisión2026-09-11

Código de productoQPC

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

PRIMED AAMI Level 3 Open Back Gowns 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 2026-09-11 under 510(k) number K262007. The device is classified under product code QPC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the PRIMED AAMI Level 3 Open Back Gowns?

PRIMED AAMI Level 3 Open Back Gowns is a medical device that received FDA 510(k) clearance on 2026-09-11. The listed applicant is PRIMED Medical Products, Inc.. The 510(k) number is K262007.

When did PRIMED AAMI Level 3 Open Back Gowns receive FDA 510(k) clearance?

PRIMED AAMI Level 3 Open Back Gowns received FDA 510(k) clearance on 2026-09-11, under 510(k) number K262007.

Who is the listed applicant for PRIMED AAMI Level 3 Open Back Gowns?

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 AAMI Level 3 Open Back Gowns?

The FDA product code for PRIMED AAMI Level 3 Open Back Gowns is QPC.

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

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)K252964PRIMED Surgical and Procedure Masks 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: QPC)

K261115VR® Personal Protective Level 4 Gown (VR Gowns)PolyConversions, Inc.K252940VR® Personal Protective Level 3 Gown (VR Gowns)PolyConversions, Inc.K242689Gorro de Protección Nivel 4 AAMI; CamisaAzac Group K233526Medline Open-back Level 3 Protective GownMedline Industries, LP K230384PolyWear® Personal Protective Level 3 GownPolyConversions, Inc.K222128Protective Gown AAMI Level 4Kenpax International Limited

Fuente oficial

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