# K062704: Sterilization Pouch with Indicators

- Pathway: 510(k) (Traditional)
- Applicant: Winner Industries (Shenzhen) Co., Ltd.
- Decided: Jun 8, 2007 after 270 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
Longest line of descent: 3 generations back to K990567 (1999). 3 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051242: Winner Self Seal Sterilization Pouch, Winner Medical (Usa), Inc. (2005) Summary page 1.
- K993764: Medipack See-Through Seal Sterilization Pouch, Medipack Medical Packaging Mfg. Co. (1999) Summary page 1.
- K990567: Global Healthcare Self-Sealing Sterilization Pouch, Global Healthcare, Inc. (1999) Summary page 1.

## Most influential descendants
- K112591: Safe Secure Sterilization Pounch with Steam and Ethylene Oxide Process Indicators (2012), 6 descendants of its own
- K153540: Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators (2016), 4 descendants of its own
- K180139: Safe Secure Sterilization Pouches and Rolls (2019), 1 descendant of its own
- K250306: Chex-All Sterilization Pouches and Tubes (2025), 0 descendants of its own
- K243431: Medicom Sterilization Pouch and Reel (2025), 0 descendants of its own

## Indications for use
Winner® Self Seal Sterilization Pouch with Steam and Ethylene Oxide Process Indicators is intended to be used to enclose another medical device that is to be sterilized by a health provider by steam 121°C for 15 minutes or greater than or equal to 600 mg/I of ethylene oxide (EtO) for 1 hour at 550 C and 70%RH. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used. The process indicators on the pouches are intended to demonstrate that the device has been exposed to the steam or EtO sterilization process and to distinguish between processed and unprocessed devices.

Source page: https://510kreport.com/device/K062704
Methodology: https://510kreport.com/methodology