# K170429: Tyvek Sterilization Pouches with Chevron Seal

- Pathway: 510(k) (Traditional)
- Applicant: Andersen Sterilizers, Inc.
- Decided: Oct 27, 2017 after 256 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 5.

## 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 the 12 hour sterilization cycle at 20-29°C in the Anprolene AN75 Ethylene Oxide Gas Sterilizer. Critical process parameters for the cycle are summarized in Table 1. Table 1. Critical sterilization cycle parameters in the Anprolene AN75 Ethylene Oxide Gas Sterilizer EO Amount Temperature Relative Humidity EO Exposure Time Total Cycle Time 17.6 g ± 5% 20-29°C 35-90% 12 hours 14 hours The product codes for Tyvek Sterilization Pouches are listed in Table 2. Table 2. Product codes for Tyvek Sterilization Pouches Product Type Self-Seal, Heat Seal, Tubing Product Codes TLP-030, TLP-031, TLP-033, TLP-058, TLP-059 The 12 hour cycle in the Anprolene AN75 Ethylene Oxide Gas Sterilizer has been validated to sterilize a load of up to 24 lbs of metal surgical instruments, 3 lbs of fabric, or 3.5 lbs of plastic devices (combined weight of pouched devices and tray). Sterility was maintained for at least 3 months after processing in an Anprolene AN75 sterilizer.

Source page: https://510kreport.com/device/K170429
Methodology: https://510kreport.com/methodology