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510(k) K934969

DUALGARD FACE SHIELD by White Knight Healthcare — Product Code FXX

K934969 is an FDA 510(k) premarket notification submitted by White Knight Healthcare for the device "DUALGARD FACE SHIELD". The FDA issued a decision of Substantially Equivalent on March 28, 1994. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. White Knight Healthcare has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 1994
Date Received
October 14, 1993
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 White Knight Healthcare

  • K001892 — WHITE KNIGHT MASKS (21 MODELS, VARIOUS COLORS WITH AND WITHOUT FACE SHIELDS) (April 3, 2001)
  • K001997 — WHITE KNIGHT BLUE, GREEN FACE MASK, (4 MODELS) (April 2, 2001)
  • K001893 — WHITE KNIGHT MASKS, BLUE, PINK, YELLOW, WHITE MASKS (13 MODELS) (April 2, 2001)
  • K951984 — WHITE KNIGHT SURGEON'S VEST (July 25, 1995)
  • K943809 — MONOGARD FACE SHIELD (November 28, 1994)
  • K942577 — SURGICAL TIP CLEANER (July 26, 1994)
  • K942576 — CLEAR LENS ENDOSCOPIC FOG REDUCTION DEVICE (July 5, 1994)

Other clearances for product code FXX

  • K251967 — HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT (March 18, 2026)
  • 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)

FDA data resources