# K974415: Kimberly-Clark Gas Plasma Sterilization Indicator Strip

- Pathway: 510(k) (Traditional)
- Applicant: Kimberly-Clark Corp.
- Decided: Jul 10, 1998 after 228 days
- Product code: JOJ (Indicator, Physical/Chemical Sterilization Process)
- Device class: 2
- Regulation: 21 CFR 880.2800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) J & J STERRAD Chemical Indicator Strip: named in the summary without a submission number

## Indications for use
The Kimberly-Clark™ Gas Plasma Indicator Strip is a chemical sterilization process indicator as defined in 21 CFR Part 880.2800(b). The indicator strip is intended to be used by a health care provider to accompany products being sterilized via a low temperature (STERRAD) sterilization process. The indicator strip is used to differentiate between product that has been exposed to hydrogen peroxide and product that has not been exposed to hydrogen peroxide. The strip will change color, from blue to green, upon exposure to the low temperature sterilant (hydrogen peroxide).

Source page: https://510kreport.com/device/K974415
Methodology: https://510kreport.com/methodology