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510(k) K061864

DUKAL SURGICAL FACE MASK TIE-ON, MODEL 1530; EAR LOOP, MODEL 1540; WITH SHIELD, MODEL 1560 by Dukal Corp. — Product Code FXX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 2006
Date Received
July 3, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mask, Surgical
Device Class
Class II
Regulation Number
878.4040
Review Panel
HO
Submission Type

Other clearances by Dukal Corp.

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  • K020726 — DUKAL DISPOSABLE VAGINAL SPECULUM, SMALL, MEDIUM, AND LARGE (May 15, 2002)
  • K984564 — ETHYL CHLORIDE DISPENSER (December 2, 1999)
  • K970457 — DUKAL ABD COMBINE PAD (May 8, 1997)
  • K970455 — DUKAL NON ADHERENT DRESSING (May 8, 1997)
  • K955476 — DUKAL TRANSPARENT WOUND DRESSING (January 18, 1996)
  • K940440 — DUKAL NON-WOVEN GAUZE (March 9, 1994)
  • K936095 — GAUZE SPONGE (February 2, 1994)

Other clearances for product code FXX

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  • K252650 — Disposable Medical Face Mask (January 5, 2026)
  • K243342 — KP Protective Face Mask (December 22, 2025)
  • K252941 — HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops (December 11, 2025)
  • K252964 — PRIMED Surgical and Procedure Masks (November 4, 2025)
  • K251902 — Vitaform Procedural Mask - Blue (Vitaform Blue); Vitaform Procedural Mask with S (September 17, 2025)
  • K250082 — Procedure mask/Surgical mask/Face mask (June 18, 2025)
  • K243010 — Fluidshield * 3 Fog-Free Surgical Mask with Wraparound Anti-Glare Visor (28804); (May 30, 2025)