# K152058: Tyvek Sterilization Pouches with Chevron Seal

- Pathway: 510(k) (Traditional)
- Applicant: Andersen Sterilizers, Inc.
- Decided: Nov 18, 2015 after 117 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: 1 generation back to K831425 (1983). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K831425: MDT Chemitest See-Thru Bag, Kenpak Converters, Inc. (1983) Summary page 5.

## Most influential descendants
- K200336: Tyvek Sterilization Pouches with Chevron Seal (2020), 0 descendants of its own
- K170429: Tyvek Sterilization Pouches with Chevron Seal (2017), 0 descendants of its own

## Indications for use
The Tyvek Sterilization Pouches with Chevron Seal are intended to be used to enclose medical devices that are to be sterilized in a single pouch configuration at a healthcare facility. They are used in the 3 hour sterilization cycle at 50°C in the EOGas 4 Ethylene Oxide Gas Sterilizer. Critical process parameters for the cycle are summarized below in Table 1. Table 1. Critical parameters for the 3 hour cycle in the EOGas 4 Ethylene Oxide Gas Sterilizer EO Amount Temperature Relative Humidity EO Exposure Time Total Cycle Time 17.6 g ± 5% 50°C ± 3°C 35-90% 3 hours 3.5 hours The 3 hour cycle in the EOGas 4 Ethylene Oxide Gas Sterilizer has been validated to sterilize a load of up to 24 lbs of metal surgical instruments or 7 lbs of plastic devices (combined weight of pouched devices and tray). 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

Source page: https://510kreport.com/device/K152058
Methodology: https://510kreport.com/methodology