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510(k) K851938

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

K851938 is an FDA 510(k) premarket notification submitted by Omni Intl., Inc. for the device "OMNIMED SURGICAL GOWN". The FDA issued a decision of Substantially Equivalent on June 28, 1985. The device falls under product code FYA (Gown, Surgical), a Class II device regulated under 21 CFR 878.4040. Omni Intl., Inc. has at least 10 other 510(k) clearances on record.

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

  • K260407 — Principle & Will ANSI/AAMI PB 70 (Sterile/Non-sterile) Level 3 Surgical Gowns (R (August 26, 2026)
  • K261028 — Surgical Gown Level2 (S, M, L, XL, XXL, XXXL) (August 7, 2026)
  • K261949 — NYES Tuff Cuff L3 Disposable Gowns (July 10, 2026)
  • K252575 — Tuff Cuff™ Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L) (June 4, 2026)
  • K260725 — BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10) (May 12, 2026)
  • K253243 — Cardinal Health™ Poly Reinforced Surgical Gown (April 28, 2026)
  • K253003 — Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown (M4025); (April 20, 2026)
  • 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)

FDA data resources