Sterivic Medical Co., Ltd. · Class II · Cleared Jan 28, 2026
| K-number | K251347 |
| Device name | Sterilization Pouch/Roll |
| Applicant | Sterivic Medical Co., Ltd. |
| Product code | FRG |
| Device class | Class II |
| Decision date | Jan 28, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 880.6850 |
The Sterilization Pouch/Roll is a medical device composed of medical-grade paper and medical compound film designed to enclose medical devices for sterilization via steam or ethylene oxide (EO) gas. It maintains sterility of enclosed devices for up to 6 months post-sterilization and has a maximum shelf life of 3 years before sterilization. The device includes external chemical ink indicators that change color (pink to yellow for EO, blue to black for steam) to show exposure to sterilization.
The subject device is composed of medical-grade paper (60g/m²) and medical compound film (50μm) with an added PU adhesive for pouch sealing. It supports both steam sterilization at 132°C for 4 minutes and EO sterilization at 50°C with 695 mg/L concentration for 4 hours. Key differences from the predicate include slightly different sterilization cycle parameters (EO concentration 695 mg/L vs. 800 mg/L; steam indicator changes blue to black vs. blue to dark grey) and shorter declared shelf life and sterility maintenance (6 months vs. 24 months post-sterilization).
ISO 11135:2014 (EO sterilization validation), ISO 17665-1:2006 (steam sterilization validation), ISO 10993 series (biocompatibility), ISO 11140-1:2014 (chemical indicators), ASTM F2251 (thickness), ISO 19244-2 (tensile strength), ASTM F88/F88M (seal strength), ASTM F1140 (burst strength), ASTM F1929 (dye penetration), ASTM F2096 (leak test), and ASTM F1980 (shelf life).
The subject device is substantially equivalent to predicate K221875 based on identical intended use (enclosing devices for steam or EO sterilization), same regulatory classification (Class II), same product codes (FRG, JOJ), and similar material composition and sterilization principles. Although sterilization cycle parameters and shelf life declarations differ, the device achieves the same sterilization assurance level (SAL 10⁻⁶) and passes identical performance testing for seal strength, burst strength, microbial barrier, and chemical indicator functionality, demonstrating equivalent safety and effectiveness.
View the full FDA submission: accessdata.fda.gov