# K193561: Diposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch

- Pathway: 510(k) (Special)
- Applicant: Weihai Xingtai Packaging Products Co., Ltd.
- Decided: Apr 15, 2020 after 114 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
Disposable Medical Device Self-Seal Sterilization Pouch The Disposable Medical Device Self-Seal Sterilization Pouch are intended to provide health care workers with an effective method to enclose devices intended for sterilization in steam auto claves and via Ethylene Oxide (EO). The intended sterilization cycles are listed below: Prevacuum steam; 4 minutes at 134 ℃; 10 minute dry time. Ethylene oxide: 1 hours at 55 ℃; relative humidity between 40%- 80%;100% ethylene oxide at dosage of 759mg/L, 12 hours aeration time at 55℃. 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 Disposable Medical Device Self-Seal Sterilization Pouch are not intended use for any load with lumen/channels and complex device. The dimension range for each of the weights used in testing: Size 57×102mm: Maximum load weight 400g Size 140x280mm: Maximum load weight 900g Size 305×455mm: Maximum load weight 1600g Disposable Medical Device Sterilization Reel Pouch The Disposable Medical Device Sterilization Reel Pouch are intended to provide health care workers with an effective method to enclose devices intended for sterilization in steam auto claves and via Ethylene Oxide (EO). The intended sterilization cycles are listed below: Prevacuum steam; 4 minutes at 134 ℃; 10 minute dry time. Ethylene oxide: 1 hours at 55 ℃; relative humidity between 40%- 80%;100% ethylene oxide at dosage of 759mg/L, 12 hours aeration time at 55℃. 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 Disposable Medical Device Self-Seal Sterilization Pouch are not intended use for any load with lumen/channels and complex device. The dimension range for each of the weights used in testing Size 50mm×200mm：Maximum load weight 400g Size 300mm×200mm：Maximum load weight 900g Size 400mm×200mm：Maximum load weight 1600g

Source page: https://510kreport.com/device/K193561
Methodology: https://510kreport.com/methodology