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510(k) K001997

WHITE KNIGHT BLUE, GREEN FACE MASK, (4 MODELS) by White Knight Healthcare, Inc. — Product Code FXX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 2, 2001
Date Received
June 30, 2000
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, Inc.

  • K001892 — WHITE KNIGHT MASKS (21 MODELS, VARIOUS COLORS WITH AND WITHOUT FACE SHIELDS) (April 3, 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)
  • K934969 — DUALGARD FACE SHIELD (March 28, 1994)

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)