# K170437: Sterisheet Sterilization Wrap

- Pathway: 510(k) (Traditional)
- Applicant: Andersen Sterilizers, Inc.
- Decided: Nov 1, 2017 after 261 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 K931202 (1993). 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)
- K152291: Sterisheet Sterilization Wrap, Andersen Sterilizers, Inc. (2015) Summary page 4.

## Indications for use
Sterisheet Sterilization Wraps are single use non-woven sterilization wraps intended to enclose medical devices that are to be sterilized 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 below 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 code for Sterisheet Sterilization Wraps is listed in Table 2. Table 2. Product code for Sterisheet Sterilization Wraps Product Designation Sterisheet S88 Blue Product Code 0129 Sizes 18”x18’’, 20”x20”, 24”x24”, 30”x30”, 36”x36”, 40”x40”, 45”x45”, 48”x48”, 54”x54”, and 54”x72” The 12 hour cycle in the Anprolene 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 wrapped devices and tray). Sterility was maintained for at least 3 months after processing in an Anprolene sterilization cycle.

Source page: https://510kreport.com/device/K170437
Methodology: https://510kreport.com/methodology