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KimGuard One-Step Sterilization Wrap

by Kimberly-Clark Health Care 510(k)

Active United States

510(k) K141612

Overview

The KimGuard One-Step Sterilization Wrap is a medical device used to enclose another medical device for sterilization by a health care provider. It is designed to provide a barrier to bacteria and liquids while allowing penetration of gas sterilants such as steam, ethylene oxide, formaldehyde, and plasma. The wrap is created from two sheets of SMS, providing six layers of protection.

The KimGuard One-Step Sterilization Wrap is supplied in various sizes, including KC100, KC200, KC300, KC400, KC500, and KC600. It is intended to be used with pre-vacuum steam at 270°F/132°C for 4 minutes or by 100% ethylene oxide with a concentration of mg/L at 131°F/55°C and 40% - 80% relative humidity for 60 minutes. The device has received FDA 510(k) authorization.

AI-generated from registry data, 22 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK141612 Date7 Aug 2014ClearedStatusActive

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
FRG
Device Class
Class II
Regulation
21 CFR Part 880.6850
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Other devices from Kimberly-Clark Health Care

Questions

  • What is the KimGuard One-Step Sterilization Wrap used for?

    The KimGuard One-Step Sterilization Wrap is used to enclose another medical device for sterilization by a health care provider, providing a barrier to bacteria and liquids.

  • How is the KimGuard One-Step Sterilization Wrap supplied?

    The KimGuard One-Step Sterilization Wrap is supplied in various sizes, including KC100, KC200, KC300, KC400, KC500, and KC600.

  • What sterilization methods are compatible with the KimGuard One-Step Sterilization Wrap?

    The device is intended to be used with pre-vacuum steam at 270°F/132°C for 4 minutes or by 100% ethylene oxide with a concentration of mg/L at 131°F/55°C and 40% - 80% relative humidity for 60 minutes.

  • Is the KimGuard One-Step Sterilization Wrap sterile?

    The description does not explicitly state that the KimGuard One-Step Sterilization Wrap is sterile, but it is designed to provide a barrier to bacteria and liquids during the sterilization process.