# K242839: Safe Secure Sterilization Pouches and Rolls

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Safesecure Medical Infection Control Tech Co., Ltd.
- Decided: Oct 16, 2024 after 27 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: 7 generations back to K990567 (1999). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180139: Safe Secure Sterilization Pouches and Rolls, Safe Secure Packing Co., Ltd. (2019) Summary page 7.

## Indications for use
Safe Secure Sterilization Pouches and Rolls are intended to be used to enclose another medical device, in a single or double pouch configuration, that is to be sterilized by a health care provider using: Gravity steam at 121°C (250°F) for 30 minutes; 25 minutes dry time Pre-vacuum steam at 132°C (270°F) for 4 minutes; 20 minutes dry time Pre-vacuum steam at 134°C (273°F) for 3 minutes; 20 minutes dry time Pre-vacuum steam at 135°C (275°F) for 3 minutes; 16 minutes dry time Ethylene Oxide (EO) with a concentration of 735 mg/L at 55°C (131°F) and 50% to 80% relative humidity for 60 minutes. Aeration time of 8 hours at 60°C (140°F). The recommended hydrogen peroxide vapor sterilization cycle is : Standard Cycle of STERRAD® 100S Standard cycle and Advanced cycle of STERRAD® NX Standard cycle, Flex cycle and Express cycle of STERRAD® 100NX Non Lumen Cycle, Lumen Cycle and Flexible Cycle of V-PRO® maX The steam and EO device are not intended and has not been validated for sterilization of devices that contain lumens. The hydrogen peroxide device has been validated for devices that contain a lumen listed below: Standard Cycle of STERRAD® 100S - inside diameter > 1 mm and length < 125 mm - inside diameter > 2 mm and length <250 mm Standard cycle of STERRAD® NX Single channel stainless steel lumens with: - Inside diameter > 1 mm and length < 150 mm - Inside diameter > 2 mm and length <400 mm Single channel PE/PTFE tubing with: - Inside diameter > 1 mm and length <350 mm Advanced cycle of STERRAD® NX Single channel stainless steel lumens with: - Inside diameter > 1 mm and length < 500 mm Single PTFE lumen tubing with: - Inside diameter > 1 mm and length < 1000 mm Single channel PE/PTFE flexible endoscopes with: - Inside diameter > 1 mm and length < 850 mm Standard cycle of STERRAD® 100NX Single channel stainless steel lumens with: - Inside diameter > 0.7 mm and length < 500 mm Single channel PE/PTFE instruments with: - Inside diameter > I mm and length < 1000 mm Flex cycle of STERRAD® 100NX Single channel PE/PTFE flexible endoscope with: - Inside diameter > 1 mm and length < 850 mm Lumen Cycle of V-PRO® maX Lumened and non-lumened instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors. Medical devices, including single, dual and triple channeled rigid and semi-rigid endoscopes, with the following configurations: Single channeled devices with a stainless lumen that is > 0.77mm internal diameter (ID) and < 500mm in length Dual channeled devices with stainless steel lumens that are > 0.77mm ID and < 527mm in length Triple channeled devices with stainless steel lumens that are ->1.2 mm ID and <275 mm in length ->1.8 mm ID and <310 mm in length or ->2.8 mm ID and <317 mm in length Flexible Cycle of V-PRO® maX Two flexible endoscopes with a light cord (if not integral to the endoscope) and mat with no additional load. The flexible endoscopes may contain either: A single lumen that is> 1 mm ID and < 1050 mm in length Or two lumens with: - One lumen that is> 1 mm ID and < 990 mm in length - And the other lumen that is > 1 mm ID and < 850 mm in length One flexible endoscope with a light cord (if not integral to endoscope) and mat and additional non-lumened instruments including instruments with diffusion-restricted areas such as the hinged portion of forceps or scissors. The flexible endoscopes my contain either: A single lumen that is> 1 mm ID and < 1050 mm in length Or two lumens with: - One lumen that is > 1 mm ID and < 990 mm in length - And the other lumen that is > 1 mm ID and < 850 mm in length The external chemical indicators on the pouches/rolls are intended to demonstrate that the device has been exposed to the steam, EO, or hydrogen peroxide sterilization process and to distinguish between processed and unprocessed devices. The chemical indicators change from green to purple or from Pink to Cocoa after exposure to steam, from yellow to brown or from Blue to Brown after exposure to ethylene oxide, and from blue to pink for hydrogen peroxide. The paper version of the pouch is for Steam and EO. The Tyvek version of the pouch is for hydrogen peroxide sterilization only. If stored according to the recommended conditions, the products before sterilization have a maximum shelf life of 5 years(for paper pouch) and 2 years(for Tyvek pouch) from the date of manufacture. The pouches are intended to allow sterilization of the enclosed medical device(s) and also to maintain sterility (SAL=10-6). The subject device is intended and has been validated to maintain sterility of the enclosed devices for 12 months after steam sterilization and 24 months after EO sterilization(for paper pouch), and, 2 years after hydrogen peroxide sterilization (for Tyvek Pouch). The maximum validated pouch load is 2.64 pounds (1.2kg).

Source page: https://510kreport.com/device/K242839
Methodology: https://510kreport.com/methodology