# K990567: Global Healthcare Self-Sealing Sterilization Pouch

- Pathway: 510(k) (Traditional)
- Applicant: Global Healthcare, Inc.
- Decided: Apr 5, 1999 after 41 days
- Product code: FRG (Wrap, Sterilization)
- 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.
31 later devices descend from it; 3 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K993764: Medipack See-Through Seal Sterilization Pouch (1999), 30 descendants of its own
- K051242: Winner Self Seal Sterilization Pouch (2005), 29 descendants of its own
- K070428: Medicom Self-Sealing Sterilization Pouch (2007), 19 descendants of its own
- K102158: Sigma Sterilization Pouch & Roll (2011), 16 descendants of its own
- K062704: Sterilization Pouch with Indicators (2007), 7 descendants of its own

## Indications for use
The sterilization wrap (pouch) is a device intended to be used to enclose another medical device that is to be sterilized using ethylene oxide or steam by a health care provider. It is intended to allow sterilization via ethylene oxide or steam of the enclosed medical device and also to maintain sterility of the enclosed device until use.

Source page: https://510kreport.com/device/K990567
Methodology: https://510kreport.com/methodology