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510(k) K780169

MASK, SURGICAL by Convertors — Product Code FXX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 13, 1978
Date Received
February 2, 1978
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 Convertors

  • K780627 — SURG-O-PAK, GOWNS, SHEETS, AND TOWELS (July 11, 1979)
  • K790234 — DRAPE PACKS, SURGICAL GOWNS (February 22, 1979)
  • K781959 — SURGICAL GOWNS, SHEETS (January 10, 1979)
  • K781534 — SURG-O-PAK PREP PAD (October 24, 1978)
  • K781099 — SURGICAL GOWNS AND DRAPES (August 14, 1978)
  • K771929 — PEDIATRICS GOWN (November 16, 1977)
  • K770933 — BIO-SHIELD CSR WRAP (September 2, 1977)
  • K770346 — ORTHOPEDIC STOCKINETTE (March 7, 1977)
  • K761034 — SURGEX SURGICAL SPONGE (January 5, 1977)

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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)