# K162258: Self Sealing Sterilization Pouches

- Pathway: 510(k) (Traditional)
- Applicant: Tianchang Jiarui Packaging Material Co., Ltd.
- Decided: Apr 28, 2017 after 260 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: 6 generations back to K990567 (1999). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143637: U&U Sterilization Pouch and Roll, U&U Medical Technology Co, Ltd. (2015) Summary page 6.

## Most influential descendants
- K183356: Disposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch (2019), 0 descendants of its own

## Indications for use
The Self Sealing Sterilization Pouches are intended to be used to enclose another medical devices that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used. The Self Sealing Sterilization Pouches are intended for sterilization of dental instruments, excluding complex devices (endoscopes and instruments with lumen/channels). The intended sterilization cycles are listed below: Prevacuum steam; 4 minutes at 132 ℃; 10 minute dry time. Ethylene oxide: 1 hours at 55 ℃; relative humidity between 40%- 80%; 100% ethylene oxide at a concentration of 740 mg/L, 7 day aeration time at 20℃. The pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or EtO sterilization process. The Self Sealing sterilization Pouches are not intended use for any load with lumen/channels and complex device. The maximum wrapped package weight for each pouch is 540g or 1.19 lbs. The sterilization pouch maintains the enclosed devices up until 6 months post sterilization. The pouches are available in the following sizes: Model(s): 57 x 102mm, 57 x 130 mm, 70 x 255 mm, 83 x 165 mm, 90 x 260 mm, 133 x 191 mm, 133 x 279 mm, 133 x 290 mm, 140 x 280 mm, 140 x 330 mm, 180 x 330 mm, 190 x 330 mm, 190 x 360 mm, 255 x 380 mm, 279 x 406 mm, 300 x 400 mm, 300 x 474 mm, 305 x 457 mm;

Source page: https://510kreport.com/device/K162258
Methodology: https://510kreport.com/methodology