Anqing Clean Dental Instrument Technology Co., Ltd. · Class II · Cleared Feb 24, 2025
| K-number | K241565 |
| Device name | Sterilization Package/Reel |
| Applicant | Anqing Clean Dental Instrument Technology Co., Ltd. |
| Product code | FRG |
| Device class | Class II |
| Decision date | Feb 24, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 880.6850 |
The Sterilization Package/Reel is a sterile barrier system designed to enclose medical devices for sterilization using steam (132°C for 4 minutes) or ethylene oxide gas (735 mg/L at 55°C for 60 minutes), and maintains sterility of enclosed devices for up to 6 months post-sterilization. It is offered in three types: self-seal pouches, flat reels, and gusseted reels, with external chemical indicators that change color to show exposure to steam or EO gas.
The subject device shares identical technological characteristics with the predicate, including the same product code (FRG, JOJ), material composition (medical dialysis paper with PET/CPP film, chemical indicators, and print ink), sterilization methods, configuration options (heat-sealing and self-sealing), and fundamental design. The main difference is a slightly shorter shelf life (2 years versus 3 years) before sterilization, though post-sterilization maintenance of sterility remains the same at 6 months.
ISO 11135:2014 (EO sterilization), ISO 17665-1:2006 and ISO TS 17665-2:2009 (steam sterilization), ISO 10993-5:2009, ISO 10993-23:2021, ISO 10993-10:2021 (biocompatibility), ISO 11140-1:2014 (chemical indicators), ASTM F2251-13, ASTM F1140/F1140M-13, ASTM F1929-15, ASTM F88/F88M-21, ISO 1924-2:2008, ASTM F2096-11, DIN 58953-6, and ISO 5636-3 (package integrity and material properties).
The subject device is substantially equivalent because it shares the same intended use, indications for use, material types, sterilization methods, and fundamental operational principles as the predicate device K212338. Both devices employ identical sterilization validation approaches and pass the same performance standards (SAL 10^-6 for both EO and steam). Although sterilization parameters differ slightly between subject and predicate, validation testing confirms the subject device fully meets ISO 11135 (EO) and ISO 17665-1 (steam) requirements. Biocompatibility testing demonstrates non-cytotoxic, non-irritating, and non-sensitizing properties equivalent to the predicate.
View the full FDA submission: accessdata.fda.gov