Primed Medical Products, Inc.

Code	Device name	Class	Specialty	Clearances	Most recent
FXX	Mask, Surgical	Class II	General, Plastic Surgery	2	2025-11-04
FRG	Wrap, Sterilization	Class II	General Hospital	2	2024-10-07
QPC	Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection	Class II	General, Plastic Surgery	1	2026-09-11
QSO	Medical Gowns With Chemotherapy Labeling Claims - Tested For Use With Chemotherapy Drugs	Class II	General, Plastic Surgery	1	2026-09-01
OXZ	Pediatric/Child Facemask	Class II	General, Plastic Surgery	1	2022-11-22

Date	K-number	Device	Code	Class	Specialty
2026-09-11	K262007	PRIMED AAMI Level 3 Open Back Gowns	QPC	Class II	General, Plastic Surgery
2026-09-01	K261811	PRIMED 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)	QSO	Class II	General, Plastic Surgery
2025-11-04	K252964	PRIMED Surgical and Procedure Masks	FXX	Class II	General, Plastic Surgery
2024-10-07	K242208	PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)	FRG	Class II	General Hospital
2024-08-26	K240286	PRIMED Surgical Masks and PRIMED Procedure Masks	FXX	Class II	General, Plastic Surgery
2024-05-24	K233777	PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)	FRG	Class II	General Hospital
2022-11-22	K213427	PRIMED Pediatric Facemask	OXZ	Class II	General, Plastic Surgery

Clearance cadence by quarter