# K152291: Sterisheet Sterilization Wrap

- Pathway: 510(k) (Traditional)
- Applicant: Andersen Sterilizers, Inc.
- Decided: Dec 17, 2015 after 126 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 K931202 (1993). 1 ancestor in all.
3 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K931202: Sterilization Wrap-Sterisheet, Arjo Wiggins Medical, Inc. (1993) Summary page 5.

## Most influential descendants
- K200335: Sterisheet Sterilization Wrap (2020), 1 descendant of its own
- K252823: Dukal Crepe Paper Sterilization Wrap (2026), 0 descendants of its own
- K170437: Sterisheet Sterilization Wrap (2017), 0 descendants of its own

## Indications for use
The 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 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 product code for the Sterisheet Sterilization Wraps is listed in Table 2. Table 2. Product code for the Sterisheet Sterilization Wraps Product Designation Sterisheet S88 Blue Product Code 0129 Maximum loads of specific materials and devices that have been validated are listed in Table 3. All validated maximum loads were processed without additional devices in the sterilizer. Sterility was maintained for at least 3 month after processing in an EOGas 4 sterilizer. Table 3. Load and material types validated in the EOGas 4 Ethylene Oxide Gas Sterilizer Device Type Maximum Load Device Examples Required Aeration Metal 24 lbs (11 kg) Surgical instruments, Metal instruments do not absorb EO; delicate sharps, including those Follow pouch or wrap manufacturer’s with hinges and mated surfaces instructions (Example: Tyvek® pouches and Sterisheet® wrap require ≥ 6 hours at 50°C). Plastic 7.0 lbs (3.2 kg) Reusable power cords, trocars 24 hours at 50°C; Fabric 6.1 lbs (2.8 kg) Reusable cloth gowns, towels Follow manufacturer’s instructions Single-lumen One (1) ≥ 2.0mm ID Gastrovideoscopes, gastrointestinal 12 hours at 50°C; Endoscope(s) ≤ 1100mm length; videoscopes Follow manufacturer’s instructions No additional devices Four (4) ≥ 1.2 mm ID Bronchoscopes, bronchovideoscopes, ≤ 700 mm length; cystoscopes, ureteroscopes, No additional devices choledocoscopes

Source page: https://510kreport.com/device/K152291
Methodology: https://510kreport.com/methodology