Skip to content

Spunguard Plus Surgical Gown

by Kimberly-Clark Corp. 510(k)

Active United States

510(k) K861600

Overview

This device is a surgical gown classified under product code FYA as a Gown, Surgical. It is designed to provide barrier protection during surgical procedures.

The Spunguard Plus Surgical Gown is supplied non-sterile and is intended for single use. It received FDA 510(k) clearance (K861600) on May 12, 1986, and is classified as a Class II device subject to special controls.

AI-generated from registry data, 19 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK861600 Date12 May 1986ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

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

Other devices from Kimberly-Clark Corporation

See all devices from Kimberly-Clark Corporation →

Questions

  • What is the Spunguard Plus Surgical Gown intended for?

    The Spunguard Plus Surgical Gown is designed to provide barrier protection during surgical procedures, as indicated by its classification under product code FYA as a Gown, Surgical.

  • Is the Spunguard Plus Surgical Gown supplied sterile or non-sterile, and is it for single use or reuse?

    The Spunguard Plus Surgical Gown is supplied non-sterile and is intended for single use only, as explicitly stated in the device description.

  • What regulatory pathway was used for the Spunguard Plus Surgical Gown, and what is its classification?

    The Spunguard Plus Surgical Gown received FDA 510(k) clearance (K861600) and is classified as a Class II device subject to special controls, based on its substantially equivalent decision.

  • When was the Spunguard Plus Surgical Gown cleared by the FDA, and what is its K number?

    The Spunguard Plus Surgical Gown received FDA 510(k) clearance on May 12, 1986, under K number K861600, as documented in the authorization and decision date fields.

  • What product code is assigned to the Spunguard Plus Surgical Gown, and what does it signify?

    The Spunguard Plus Surgical Gown is assigned product code FYA, which signifies its classification as a Gown, Surgical, according to the device data.