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Omnimed Surgical Gown

by Omni Intl., Inc.

510(k) K851938

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK851938 Date28 Jun 1985ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FYA
Device Class
Class II
Regulation
21 CFR Part 878.4040
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Omnimed Surgical Gown is a non‑woven isolation gown intended for use as personal protective equipment during surgical and procedural activities. It provides a barrier to fluids and contaminants and is constructed from polypropylene to offer comfort and breathability for the wearer.

The gown is marketed by Omni Intl., Inc. and has received a traditional FDA 510(k) clearance (K851938) with a decision of substantially equivalent. It is classified under product code FYA and was cleared on 28 June 1985. The device is supplied by the manufacturer and is identified by the name Omnimed Surgical Gown.

Other devices from Omni Intl., Inc.

See all devices from Omni Intl., Inc. →

Questions

AI-generated answers, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Omnimed Surgical Gown used for?

    The Omnimed Surgical Gown is intended for use as personal protective equipment during surgical and procedural activities, providing a barrier to fluids and contaminants to protect the wearer and maintain a sterile field.

  • How is the Omnimed Surgical Gown supplied and is it sterile?

    The Omnimed Surgical Gown is supplied by the manufacturer Omni Intl., Inc. as a non-sterile isolation gown; it is not indicated as sterile in the provided data, so users should follow facility protocols for sterilization if required for specific procedures.

  • What material is the Omnimed Surgical Gown made from and what are its properties?

    The Omnimed Surgical Gown is constructed from polypropylene, which offers comfort and breathability for the wearer while providing an effective barrier against fluids and contaminants during use.

  • What regulatory clearance does the Omnimed Surgical Gown have?

    The Omnimed Surgical Gown has received a traditional FDA 510(k) clearance (K851938) with a decision of substantially equivalent, classified under product code FYA, and was cleared on June 28, 1985.