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510(k) K913043

MODIFICATION TECNOL FLUIDSHIELD SURGICAL MASKS by Tecnol New Jersey Wound Care, Inc. — Product Code FXX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 23, 1991
Date Received
June 20, 1991
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 Tecnol New Jersey Wound Care, Inc.

  • K911891 — FLUIDSHIELD(TM) CONE CLASSIC(TM) II SURGICAL MASK (July 12, 1991)
  • K911907 — FLUIDSHIELD CONE CLASSIC II SURG MASK W/SPLASH VIS (July 8, 1991)
  • K896193 — TECNOL LAZER(TM) SURGICAL MASK (February 27, 1990)
  • K894205 — TECNOL SILK STRIP (July 25, 1989)
  • K893702 — TECNOL GAITERS PRODUCT NUMBER 47725-010 (June 23, 1989)
  • K891187 — TECNOL NASO-GASTRIC TUBE HOLDER (May 30, 1989)
  • K891178 — TECNOL SECURE-ALL TUBE HOLDER (May 23, 1989)
  • K884440 — TECNOL VARIABLE TENSION BANDAGE (January 17, 1989)
  • K882640 — TECNOL SECURE-ALL PELVIC TRACTION BELT (July 27, 1988)
  • K882641 — TECNOL CATHETER LEG STRAP (July 12, 1988)

Other clearances for product code FXX

  • K252534 — Surgical Face Mask (Ear mount) (March 3, 2026)
  • K253398 — Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300) (February 19, 2026)
  • K252830 — Disposable Surgical Face Mask (3P00B, C2900) (January 12, 2026)
  • 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)