# K973827: Kimberly-Clark Self-Seal Pouch for Low Temperature Sterilization

- Pathway: 510(k) (Traditional)
- Applicant: Kimberly-Clark Corp.
- Decided: Feb 11, 1998 after 127 days
- Product code: KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories)
- Device class: 2
- Regulation: 21 CFR 880.6850
- 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) Medi-Oxide Sterilization Pouch: named in the summary without a submission number

## Indications for use
The Kimberly-Clark™ Self-Seal Pouch for Low Temperature Sterilization is intended to be used to enclose another medical device that is to be sterilized by a health care provider and to maintain sterility of the enclosed device until needed. The sterilization pouch is intended for use with low temperature sterilization processes (hydrogen peroxide gas plasma/STERRAD® Sterilization System, peracetic acid gas plasma/Plazlyte Sterilization Process or ethylene oxide).

Source page: https://510kreport.com/device/K973827
Methodology: https://510kreport.com/methodology