# K200336: Tyvek Sterilization Pouches with Chevron Seal

- Pathway: 510(k) (Traditional)
- Applicant: Andersen Sterilizers, Inc.
- Decided: Nov 12, 2020 after 275 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: 2 generations back to K831425 (1983). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152058: Tyvek Sterilization Pouches with Chevron Seal, Andersen Sterilizers, Inc. (2015) Summary page 6.

## Indications for use
Tyvek Sterilization Pouches with Chevron Seal are intended to enclose medical devices that are to be sterilized in a single pouch configuration at a healthcare facility. They are used in 3-hour and 6-hour gas exposures at 50°C in the EOGas 4 Ethylene Oxide Gas Sterilizer. Critical process parameters for the cycle are summarized in Table 1. Table 1. Critical sterilization cycle parameters in the EOGas 4 Ethylene Oxide Gas Sterilizer Ethylene Oxide Temperature Relative Humidity EO Exposure Time Total Cycle Time 17.6 g ± 5% 50°C ± 3°C 35-70% 3 hours 3.5 hours 6 hours 7 hours The EOGas 4 Ethylene Oxide Gas Sterilizer 3-hour gas exposure is used for surface sterilization of medical devices, including instruments with diffusion-restricted spaces (hinges or mated surfaces), as well as for the sterilization of endoscopes working length shorter than 1100 mm as specified in the sterilizer labeling. The EOGas 4 Ethylene Oxide Gas Sterilizer 6-hour gas exposure is used for sterilization of duodenoscopes and colonoscopes with working length longer than 1100 mm as specified in the sterilizer labeling.

Source page: https://510kreport.com/device/K200336
Methodology: https://510kreport.com/methodology