Home / 510(k) Clearances / K851938

510(k) K851938

OMNIMED SURGICAL GOWN by Omni Intl., Inc. — Product Code FYA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 1985
Date Received
May 3, 1985
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 Omni Intl., Inc.

  • K984066 — OMNIGRIP, LATEX SURGICAL GLOVE, POWDER-FREE WITH PROTEIN LABELING CLAIM (January 13, 1999)
  • K984064 — OMNIGRIP, LATEX SURGICAL GLOVE, POWDER FREE (January 8, 1999)
  • K853255 — OMNIMED I.V. SOLUTION ADMIN. SET (August 23, 1985)
  • K851654 — OMNIMED CLAMP (May 31, 1985)
  • K851734 — OMNIMED SUPERIOR TRANSDUCER PROTECTOR (May 23, 1985)
  • K850706 — F-SERIES IMPLANT (April 10, 1985)
  • K850112 — OMNIMED IV SOLUTION ADMINISTRATION SET (February 22, 1985)
  • K850066 — OMNIMED NASAL OXYGEN CANNULA (January 24, 1985)
  • K831147 — OMNIPROBE ELECTRICAL NERVE STIMULATOR (July 18, 1983)
  • K821523 — OMNI TENS (June 16, 1982)

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)