Home / 510(k) Clearances / K241214

510(k) K241214

ProPel SG3™ Surgical Gown by Standard Textile Co., Inc. — Product Code FYA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 10, 2024
Date Received
April 30, 2024
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 Standard Textile Co., Inc.

  • K172207 — Standard Supreme Sterilization Wrapper (August 25, 2017)
  • K162162 — Barrier Supreme Sterilization Wrapper (November 4, 2016)
  • K060181 — COMPE1 1 -PLY SURGICAL GOWNS (March 7, 2006)
  • K041653 — COMPEL 1-PLY SURGICAL GOWNS; COMPEL ISOLATION GOWNS (July 1, 2005)
  • K041540 — COMBOSAFE (EUROPE) AND PROMAX (US) SURGICAL GOWNS (May 5, 2005)
  • K041539 — COMPEL SURGICAL GOWNS (April 28, 2005)
  • K041541 — COMPEL MLR SURGICAL GOWNS (March 16, 2005)
  • K012268 — TRIMAX (December 3, 2001)
  • K012807 — MODIFICATION TO: COMPEL SURGICAL DRAPES (October 11, 2001)
  • K010799 — COMBOSAFE SURGICAL GOWNS, NON-STERILE (75X REUSABLE) (June 7, 2001)

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)
  • K233571 — GCI Surgical Gown (August 2, 2024)
  • K233068 — Disposable Surgical Gown (March 29, 2024)
  • K233183 — Surgical Gown (40083) (February 1, 2024)