# K181957: Heat Sealing Sterilization Pouch Flat, Heat Sealing Sterilization Pouch Gusseted, Heat Sealing Sterilization Pouch Roll Flat, Heat Sealing Sterilization Pouch Roll Gusseted

- Pathway: 510(k) (Traditional)
- Applicant: Tianchang Jiarui Packaging Material Co., Ltd.
- Decided: Jul 9, 2019 after 351 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.
No later device cites it as a predicate yet.
0 of 7 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 10.

## Indications for use
The Heat Sealing Sterilization Pouch Flat 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 Heat Sealing Sterilization Pouch Flat 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 Heat Sealing Sterilization Pouch Flat are not intended use for any load with lumen/channels and complex device. The maximum wrapped package weight for 500 x 600 mm size pouch is 1470 g, 200 x 300 mm size pouch is 300g, 90 x 559 mm size pouch is 250g, and 102 x 203 size pouch is 110g. The sterilization pouch maintains the sterility of the enclosed devices for up to 6 months post sterilization. Heat Sealing Sterilization Pouch Gusseted The Heat Sealing Sterilization Pouch Gusseted 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 Heat Sealing Sterilization Pouch Gusseted 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 Heat Sealing Sterilization Pouch Gusseted are not intended use for any load with lumen/channels and complex device. The maximum wrapped package weight for 300 x 65 x 560 mm size pouch is 1050g, 200 x 33 x 340 mm size pouch is 400g, and 65 x 40 x 254 mm size pouch is 200g. The sterilization pouch maintains the sterility of the enclosed devices for up to 6 months post sterilization. Device Size (mm): 65ⅹ40ⅹ254,70 x 35 x 145,90 x 50 x 155,128 x 50 X 190,137ⅹ40ⅹ305, 150ⅹ50ⅹ380, 165ⅹ75ⅹ295, 200ⅹ33ⅹ340, 200ⅹ98ⅹ440,250ⅹ60ⅹ340,250ⅹ60ⅹ480,300ⅹ65ⅹ560. Heat Sealing Sterilization Pouch Roll Flat The Heat Sealing Sterilization Roll Flat 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 Heat Sealing Sterilization Roll Flat 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 Heat Sealing Sterilization Roll Flat are not intended use for any load with lumen/channels and complex device. The maximum wrapped package weight for 600 x 200 mm size pouch is 910g, 300 x 200 mm size pouch is 450g and 50 x 200 mm size pouch is 100g. The sterilization roll maintains the sterility of the enclosed devices for up to 6 months post sterilization. Device Size (mm): 50 x 200,75 x 200,100 x 200,120 x 200,150 x 200,200 x 200,250 x 200,300 x 200,350 x 200, 400 x 200, 500 x 200,600 x 200. Heat Sealing Sterilization Pouch Roll Gusseted The Heat Sealing Sterilization Roll Gusseted 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 Heat Sealing Sterilization Roll Gusseted 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 Heat Sealing Sterilization Roll Gusseted are not intended use for any load with lumen/channels and complex device. The maximum wrapped package weight for 500 x 100 mm size pouch is 750g, 250 x 100 mm size pouch is 375g and 75 x 100 mm size pouch is 100g. The sterilization roll maintains the sterility of the enclosed devices for up to 6 months post sterilization. Device Size (mm): 75 x 100,100 x 100,150 x 100,200 x 100,250x 100,300 x 100,350 x 100,400 x 100,500 x 100.

Source page: https://510kreport.com/device/K181957
Methodology: https://510kreport.com/methodology