FRG · Wrap, Sterilization
General Hospital · 21 CFR 880.6850 · Class 2
Overview
| Product Code | FRG |
|---|---|
| Device Name | Wrap, Sterilization |
| Regulation | 21 CFR 880.6850 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
| 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 | Sterilization Pouch/Roll | Sterivic Medical Co., Ltd. | Jan 28, 2026 | SESE |
| K251177 | Self-Seal Sterilization Pouch and Roll | Guangdong Maidi Medical Co., Ltd. | Dec 12, 2025 | SESE |
| K250306 | Chex-All Sterilization Pouches and Tubes | Propper Manufacturing Co., Inc. | Oct 31, 2025 | SESE |
| K243179 | Sterilization Pouch and Roll | Yichang Xinxin Paper Products Co., Ltd. | Jun 26, 2025 | SESE |
| K250321 | GCI Sterilization Wrappers | George Courey, Inc. | Jun 6, 2025 | SESE |
| K243721 | Self Sealing Sterilization Pouches | Wellmed Dental Medical Supply Co., Ltd. | Apr 25, 2025 | SESE |
| K250011 | Turbett Surgical Instrument Pod (TS1500); Turbett Surgical Instrument Pod (TS1200); Turbett Surgical Instrument Pod (TS1000) | Turbett Surgical | Apr 4, 2025 | SESE |
| K241565 | Sterilization Package/Reel | Anqing Clean Dental Instrument Technology Co., Ltd. | Feb 24, 2025 | SESE |
| K243431 | Medicom Sterilization Pouch and Reel | Medicom Asia-Pacific Holdings Ltd. Taiwan Branch. | Feb 21, 2025 | SESE |
| K242898 | Sterilization Pouches and Reels | Shanghai Jianzhong Medical Packaging Co., Ltd. | Feb 21, 2025 | SESE |
| K240438 | CDB Hospital ® Sterilization Wrap (70 gsm); CDB Hospital ® Sterilization Wrap (44 gsm) | Comercializadora Brever | Nov 4, 2024 | SESE |
| K242839 | Safe Secure Sterilization Pouches and Rolls | Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd. | Oct 16, 2024 | SESE |
| K242208 | PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) | Primed Medical Products, Inc. | Oct 7, 2024 | SESE |
| K241123 | Perpak Sterilization Tyvek Pouch | Km Corp. | Sep 18, 2024 | SESE |
| K234132 | Medline Reusable Sterilization Wrappers | Medline Industries, LP | Sep 17, 2024 | SESE |
| K234050 | 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 | HALYARD* SMART-FOLD* Sterilization Wrap (H450); HALYARD* SMART-FOLD* Sterilization Wrap (H650) | O&M Halyard, Inc. | Aug 7, 2024 | SESE |
| K240862 | Medicom Sterilization Wrap | Medicom Group, Inc. | Jun 21, 2024 | SESE |
| K232625 | Steriking® Pouch for Robotic Instruments | Wipak OY | Jun 7, 2024 | SESE |
| K233777 | 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
