Home / 510(k) Clearances / K781099

510(k) K781099

SURGICAL GOWNS AND DRAPES by Convertors — Product Code FYA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 1978
Date Received
July 3, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gown, 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)
  • K780169 — MASK, SURGICAL (February 13, 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)

Other clearances for product code FYA

  • K251860 — Copioumed AAMI 3 Surgical Gown (February 26, 2026)
  • K252301 — Henan Yadu Level 4 Surgical Gowns (Reinforced) (February 4, 2026)
  • K250564 — Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL) (December 3, 2025)
  • K243522 — ViVi® Toga Premium (May 30, 2025)
  • K242937 — Dream Medi Sterile Surgical Gown (SurgicalGownUL) (May 5, 2025)
  • K242844 — Medline Level 4 Surgical Gown with Breathable Sleeves (February 26, 2025)
  • K241272 — Stryker Steri-Shield 8 Surgical Hoods and Togas (October 16, 2024)
  • K241214 — ProPel SG3™ Surgical Gown (September 10, 2024)
  • K233571 — GCI Surgical Gown (August 2, 2024)
  • K233068 — Disposable Surgical Gown (March 29, 2024)