Dukal Corporation

Code	Device name	Class	Specialty	Clearances	Most recent
FRG	Wrap, Sterilization	Class II	General Hospital	2	2026-05-28
FXX	—	—	—	2	2021-02-16
QPC	—	—	—	1	2022-03-30
OXZ	Pediatric/Child Facemask	Class II	General, Plastic Surgery	1	2022-03-29
FYA	Gown, Surgical	Class II	General, Plastic Surgery	1	2022-03-18

Date	K-number	Device	Code	Class	Specialty
2026-05-28	K252823	Dukal Crepe Paper Sterilization Wrap	FRG	Class II	General Hospital
2024-03-22	K233262	Dukal SMS Sterilization Wrap	FRG	Class II	General Hospital
2022-03-30	K212464	Dukal Corporation AAMI Level 4 Open-Back Protective Gown	QPC	—	—
2022-03-29	K210321	Dukal Corporation Level 1 Pediatric Face Mask	OXZ	Class II	General, Plastic Surgery
2022-03-18	K203237	Dukal Sterile AAMI Level 3 Reinforced Surgical Gown, Sterile AAMI Level 3 Surgical Gown, Sterile AAMI Level 4 Surgical Gown, and Sterile AAMI Level 4 Splicing Surgical Gown	FYA	Class II	General, Plastic Surgery
2021-02-16	K201732	Dukal Corporation Level 3 Surgical Face Masks with Ear loop, Dukal Corporation Level 3 Surgical Face Masks with Tie On	FXX	—	—
2021-02-05	K201421	Dukal Corporation Level 2 Surgical Mask with Ear Loops; Dukal Corporation Level 2 Surgical Mask with Ear Loops and Face Shield; Dukal Corporation Level 2 Surgical Mask with Adjustable Tie Ons	FXX	—	—

Clearance cadence by quarter