Browse hierarchy: [General Hospital (HO)](/submissions/HO) → [Subpart G — General Hospital and Personal Use Miscellaneous Devices](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices) → [21 CFR 880.6850](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/880.6850) → FRG — Wrap, Sterilization # FRG · Wrap, Sterilization _General Hospital · 21 CFR 880.6850 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FRG ## Overview - **Product Code:** FRG - **Device Name:** Wrap, Sterilization - **Regulation:** [21 CFR 880.6850](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/880.6850) - **Device Class:** 2 - **Review Panel:** [General Hospital](/submissions/HO) - **3rd-party reviewable:** yes ## Identification A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 320) Showing 20 most recent of 320 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K251347](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FRG/K251347.md) | Sterilization Pouch/Roll | Sterivic Medical Co., Ltd. | Jan 28, 2026 | SESE | | [K251177](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FRG/K251177.md) | Self-Seal Sterilization Pouch and Roll | Guangdong Maidi Medical Co., Ltd. | Dec 12, 2025 | SESE | | [K250306](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FRG/K250306.md) | Chex-All Sterilization Pouches and Tubes | Propper Manufacturing Co., Inc. | Oct 31, 2025 | SESE | | [K243179](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FRG/K243179.md) | Sterilization Pouch and Roll | Yichang Xinxin Paper Products Co., Ltd. | Jun 26, 2025 | SESE | | [K250321](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FRG/K250321.md) | GCI Sterilization Wrappers | George Courey, Inc. | Jun 6, 2025 | SESE | | [K243721](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FRG/K243721.md) | Self Sealing Sterilization Pouches | Wellmed Dental Medical Supply Co., Ltd. | Apr 25, 2025 | SESE | | [K250011](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FRG/K250011.md) | Turbett Surgical Instrument Pod (TS1500); Turbett Surgical Instrument Pod (TS1200); Turbett Surgical Instrument Pod (TS1000) | Turbett Surgical | Apr 4, 2025 | SESE | | [K241565](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FRG/K241565.md) | Sterilization Package/Reel | Anqing Clean Dental Instrument Technology Co., Ltd. | Feb 24, 2025 | SESE | | [K243431](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FRG/K243431.md) | Medicom Sterilization Pouch and Reel | Medicom Asia-Pacific Holdings Ltd. Taiwan Branch. | Feb 21, 2025 | SESE | | [K242898](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FRG/K242898.md) | Sterilization Pouches and Reels | Shanghai Jianzhong Medical Packaging Co., Ltd. | Feb 21, 2025 | SESE | | [K240438](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FRG/K240438.md) | CDB Hospital ® Sterilization Wrap (70 gsm); CDB Hospital ® Sterilization Wrap (44 gsm) | Comercializadora Brever | Nov 4, 2024 | SESE | | [K242839](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FRG/K242839.md) | Safe Secure Sterilization Pouches and Rolls | Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd. | Oct 16, 2024 | SESE | | [K242208](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FRG/K242208.md) | PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) | Primed Medical Products, Inc. | Oct 7, 2024 | SESE | | [K241123](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FRG/K241123.md) | Perpak™ Sterilization Tyvek Pouch | Km Corp. | Sep 18, 2024 | SESE | | [K234132](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FRG/K234132.md) | Medline Reusable Sterilization Wrappers | Medline Industries, LP | Sep 17, 2024 | SESE | | [K234050](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FRG/K234050.md) | HALYARD® ONE-STEP® Sterilization Wrap, HALYARD® QUICK CHECK® Sterilization Wrap, HALYARD® SEQUENTIAL Sterilization Wrap and HALYARD® SMART-FOLD® Sterilization Wrap | O&M Halyard, Inc. | Sep 16, 2024 | SESE | | [K240330](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FRG/K240330.md) | HALYARD* SMART-FOLD* Sterilization Wrap (H450); HALYARD* SMART-FOLD* Sterilization Wrap (H650) | O&M Halyard, Inc. | Aug 7, 2024 | SESE | | [K240862](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FRG/K240862.md) | Medicom Sterilization Wrap | Medicom Group, Inc. | Jun 21, 2024 | SESE | | [K232625](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FRG/K232625.md) | Steriking® Pouch for Robotic Instruments | Wipak OY | Jun 7, 2024 | SESE | | [K233777](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FRG/K233777.md) | PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) | Primed Medical Products, Inc. | May 24, 2024 | SESE | ## Top Applicants - Cardinal Health200, LLC — 11 clearances - Kimberly-Clark Corp. — 11 clearances - Case Medical, Inc. — 9 clearances - Medline Industries, Inc. — 9 clearances - Custom Pack Reliability — 7 clearances --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FRG](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FRG) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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