Home / 510(k) Clearances / K990395

510(k) K990395

BARRIER SURGICAL GOWNS by Johnson & Johnson Medical, Div. of Ethicon, Inc. — Product Code FYA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 13, 1999
Date Received
February 9, 1999
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 Johnson & Johnson Medical, Div. of Ethicon, Inc.

  • K990236 — MODIFICATION OF JELCO*,JELCO*-W AND JELCO* PLUS I.V. CATHETERS, CATHLON* I.V. CA (August 20, 1999)
  • K983240 — NEUTRALON PF POWDER FREE BROWN LATEX SURGICAL GLOVES (November 30, 1998)
  • K983234 — TIELLE PLUS HYDROPOLYMER ADHESIVE DRESSING (November 25, 1998)
  • K983394 — MODIFICATION TO TIELLE HYDROPOLMER DRESSING (November 3, 1998)

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)