# K182184: Paper Sterilization Pouch and Roll (Sterilization Pouch Flat, Sterilization Pouch Gusseted, Sterilization Roll Flat and Sterilization Roll Gusseted)

- Pathway: 510(k) (Traditional)
- Applicant: Mdk (Shanghai) Medical Packing Co., Ltd.
- Decided: Oct 10, 2019 after 423 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 6.

## Indications for use
Sterilization Pouch Flat The 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 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: Gravity Steam; 30 minutes at 121 ℃; 25 minutes dry time. Ethylene oxide: 4 hours at 55 ℃; relative humidity between 50%- 85%; ethylene oxide concentration is 600 mg/L, 8 hours aeration time at 60℃. 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 Sterilization Pouch Flat are not intended use for any load with lumen/channels and complex device. The maximum wrapped package weight for each pouch is 1470 g. The sterilization pouch maintains the enclosed devices up until 6 months post sterilization. Sterilization Pouch Gusseted The 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 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: Gravity Steam; 30 minutes at 121 ℃; 25 minutes dry time. Ethylene oxide: 4 hours at 55 ℃; relative humidity between 50%- 85%; ethylene oxide concentration is 600 mg/L, 8 hours aeration time at 60℃. 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 Sterilization Pouch Gusseted are not intended use for any load with lumen/channels and complex device. The maximum wrapped package weight for each pouch is 1470g. The sterilization pouch maintains the enclosed devices up until 6 months post sterilization. Sterilization Roll Flat The 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 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: Gravity Steam; 30 minutes at 121 ℃; 25 minutes dry time. Ethylene oxide: 4 hours at 55 ℃; relative humidity between 50%- 85%; ethylene oxide concentration is 600 mg/L, 8 hours aeration time at 60℃. 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 Sterilization Roll Flat are not intended use for any load with lumen/channels and complex device. The maximum wrapped package weight for each pouch is 910g. The sterilization roll maintains the enclosed devices up until 6 months post sterilization. Sterilization Roll Gusseted The 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 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: Gravity Steam; 30 minutes at 121 ℃; 25 minutes dry time. Ethylene oxide: 4 hours at 55 ℃; relative humidity between 50%- 85%; ethylene oxide concentration is 600 mg/L, 8 hours aeration time at 60℃. 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 Sterilization Roll Gusseted are not intended use for any load with lumen/channels and complex device. The maximum wrapped package weight for each pouch is 910g. The sterilization roll maintains the enclosed devices up until 6 months post sterilization.

Source page: https://510kreport.com/device/K182184
Methodology: https://510kreport.com/methodology