FDA Product Code
FDA Product Code FRG — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 880.6850
510(k) Clearances — 323 records · page 1 of 4
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261897 | HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* HEAVY-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* STANDARD-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* H300W Sterilization Wrap with ASSURE-DRY* Technology | O&M Halyard, Inc. | 2026-07-02 | Traditional | PDF ↗ |
| K252823 | Dukal Crepe Paper Sterilization Wrap | Dukal, LLC | 2026-05-28 | Traditional | PDF ↗ |
| K253454 | HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL Sterilization Wrap; HALYARD* SMART-FOLD* Sterilization Wrap | O&M Halyard, Inc. | 2026-05-18 | Traditional | PDF ↗ |
| K251347 | Sterilization Pouch/Roll | Sterivic Medical Co., Ltd. | 2026-01-28 | Traditional | PDF ↗ |
| K251177 | Self-Seal Sterilization Pouch and Roll | Guangdong Maidi Medical Co., Ltd. | 2025-12-12 | Traditional | PDF ↗ |
| K250306 | Chex-All Sterilization Pouches and Tubes | Propper Manufacturing Co., Inc. | 2025-10-31 | Abbreviated | PDF ↗ |
| K243179 | Sterilization Pouch and Roll | Yichang Xinxin Paper Products Co., Ltd. | 2025-06-26 | Traditional | PDF ↗ |
| K250321 | GCI Sterilization Wrappers | George Courey, Inc. | 2025-06-06 | Traditional | PDF ↗ |
| K243721 | Self Sealing Sterilization Pouches | Wellmed Dental Medical Supply Co., Ltd. | 2025-04-25 | Traditional | PDF ↗ |
| K250011 | Turbett Surgical Instrument Pod (TS1500); Turbett Surgical Instrument Pod (TS1200); Turbett Surgical Instrument Pod (TS1000) | Turbett Surgical | 2025-04-04 | Traditional | PDF ↗ |
| K241565 | Sterilization Package/Reel | Anqing Clean Dental Instrument Technology Co., Ltd. | 2025-02-24 | Traditional | PDF ↗ |
| K242898 | Sterilization Pouches and Reels | Shanghai Jianzhong Medical Packaging Co., Ltd. | 2025-02-21 | Traditional | PDF ↗ |
| K243431 | Medicom Sterilization Pouch and Reel | Medicom Asia-Pacific Holdings Ltd. Taiwan Branch. | 2025-02-21 | Traditional | PDF ↗ |
| K240438 | CDB Hospital ® Sterilization Wrap (70 gsm); CDB Hospital ® Sterilization Wrap (44 gsm) | Comercializadora Brever | 2024-11-04 | Traditional | PDF ↗ |
| K242839 | Safe Secure Sterilization Pouches and Rolls | Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd. | 2024-10-16 | Traditional | PDF ↗ |
| K242208 | PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) | Primed Medical Products, Inc. | 2024-10-07 | Traditional | PDF ↗ |
| K241123 | Perpak Sterilization Tyvek Pouch | Km Corp. | 2024-09-18 | Traditional | PDF ↗ |
| K234132 | Medline Reusable Sterilization Wrappers | Medline Industries, LP | 2024-09-17 | Traditional | PDF ↗ |
| 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. | 2024-09-16 | Traditional | PDF ↗ |
| K240330 | HALYARD* SMART-FOLD* Sterilization Wrap (H450); HALYARD* SMART-FOLD* Sterilization Wrap (H650) | O&M Halyard, Inc. | 2024-08-07 | Traditional | PDF ↗ |
| K240862 | Medicom Sterilization Wrap | Medicom Group, Inc. | 2024-06-21 | Traditional | PDF ↗ |
| K232625 | Steriking® Pouch for Robotic Instruments | Wipak OY | 2024-06-07 | Traditional | PDF ↗ |
| K233777 | PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) | Primed Medical Products, Inc. | 2024-05-24 | Traditional | PDF ↗ |
| K233262 | Dukal SMS Sterilization Wrap | Dukal, LLC | 2024-03-22 | Traditional | PDF ↗ |
| K230137 | Reliance® Fusion Sterilization Wraps | Ahlstrom-Munksjo Nonwovens, LLC | 2023-12-07 | Traditional | PDF ↗ |
| K231999 | Steriking® LT-Blueline Pouches with Tyvek® | Wipak OY | 2023-09-07 | Special | PDF ↗ |
| K231996 | Steriking® LT-Blueline Pouches with Tyvek® | Wipak OY | 2023-09-07 | Special | PDF ↗ |
| K223600 | Sterilization Wrap | Wuhan Zonsen Medical Products Co., Ltd. | 2023-08-25 | Traditional | PDF ↗ |
| K231500 | Vis-U-All Low Temperature Sterilization Pouches | STERIS Corporation | 2023-08-07 | Traditional | PDF ↗ |
| K223025 | Tyvek Roll with CI for STERLINK Sterilizer | Plasmapp Co,., Ltd. | 2023-05-09 | Traditional | PDF ↗ |
| K222151 | Sterilization Wrap | Kenpax International Limited | 2023-03-23 | Traditional | PDF ↗ |
| K221875 | Sterilization Pouch and Roll | Qianjiang Kingphar Medical Packaging & Printing Co., Ltd. | 2023-02-13 | Traditional | PDF ↗ |
| K221379 | Steriking LT-Blueline Pouches with Tyvek | Wipak OY | 2023-01-04 | Traditional | PDF ↗ |
| K221377 | SteriKing LT-Blueline Pouches with Tyvek | Wipak OY | 2022-12-22 | Traditional | PDF ↗ |
| K220365 | Gemini Sterilization Wrap | Medline Industries, LP | 2022-10-06 | Traditional | PDF ↗ |
| K222440 | Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization Trays | Steris | 2022-09-09 | Special | PDF ↗ |
| K191131 | Solidence Multipockets | Solidence Surgical Corporation | 2022-08-03 | Traditional | PDF ↗ |
| K214007 | HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization Wrap | Owens & Minor (O&M) Halyard, Inc. | 2022-07-27 | Traditional | PDF ↗ |
| K221016 | Steriking Packaging for Medical Devices | Wipak OY | 2022-05-05 | Special | PDF ↗ |
| K213907 | CareGUARD Sterilization Wrap | Care Essentials Pty, Ltd. | 2022-03-14 | Traditional | PDF ↗ |
| K220133 | Sterilization Wraps | Weihai Hongyu Nonwoven Fabric Products Co., Ltd. | 2022-03-10 | Traditional | PDF ↗ |
| K210810 | Steiking Packaging for Medical Devices | Wipak OY | 2022-01-23 | Traditional | PDF ↗ |
| K212338 | SterileRight sterilization pouch and roll | Sterileright Packaging Mfg., Inc. | 2021-11-01 | Traditional | PDF ↗ |
| K212198 | Tyvek(R) Roll with CI for STERLINKTM Sterilizer | Plasmapp Co,., Ltd. | 2021-10-22 | Traditional | PDF ↗ |
| K202593 | Turbett Instrument Pod | Turbett Surgical, Inc. | 2021-05-19 | Traditional | PDF ↗ |
| K202462 | SIGMA Sterilization Pouch and Roll | Sigma Medical Supplies Corporation | 2021-04-23 | Abbreviated | PDF ↗ |
| K200336 | Tyvek Sterilization Pouches with Chevron Seal | Andersen Sterilizers, Inc. | 2020-11-12 | Traditional | PDF ↗ |
| K200335 | Sterisheet Sterilization Wrap | Andersen Sterilizers, Inc. | 2020-11-12 | Traditional | PDF ↗ |
| K200240 | Turbett Instrument Pod | Turbett Surgical, Inc. | 2020-04-30 | Traditional | PDF ↗ |
| K193561 | Diposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch | Weihai Xingtai Packaging Products Co., Ltd. | 2020-04-15 | Special | PDF ↗ |
| K192641 | Gemini Titan Sterilization Wrap | Medline Industries, Inc. | 2020-01-24 | Traditional | PDF ↗ |
| K192147 | Halyard ONE-STEP* Sterilization Wrap | Owens & Minor (O&M) Halyard, Inc. | 2019-10-10 | Traditional | PDF ↗ |
| K182184 | Paper Sterilization Pouch and Roll(Sterilization Pouch Flat, Sterilization Pouch Gusseted, Sterilization Roll Flat and Sterilization Roll Gusseted) | Mdk (Shanghai) Medical Packing Co., Ltd. | 2019-10-10 | Traditional | PDF ↗ |
| K183356 | Disposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch | Weihai Xingtai Packaging Products Co., Ltd. | 2019-08-19 | Traditional | PDF ↗ |
| K181957 | Heat Sealing Sterilization Pouch Flat, Heat Sealing Sterilization Pouch Gusseted, Heat Sealing Sterilization Pouch Roll Flat, Heat Sealing Sterilization Pouch Roll Gusseted | Tianchang Jiarui Packaging Material Co., Ltd. | 2019-07-09 | Traditional | PDF ↗ |
| K182656 | JAMBRO Single Core A Sterilization wrap | Jiangsu Zhande Medical Supplies Co., Ltd. | 2019-06-11 | Traditional | PDF ↗ |
| K181959 | HALYARD SMART-FOLD* Sterilization Wrap (H450, H650) | Owens & Minor Halyard, Inc. | 2019-03-22 | Traditional | PDF ↗ |
| K183401 | Vis-U-All Low Temperature Sterilization Pouch/Tubing | STERIS Corporation | 2019-03-01 | Traditional | PDF ↗ |
| K180139 | Safe Secure Sterilization Pouches and Rolls | Safe Secure Packing Co., Ltd. | 2019-01-03 | Traditional | PDF ↗ |
| K183297 | Vis-U-All Low Temperature Sterilization Pouch/Tubing | STERIS Corporation | 2019-01-03 | Traditional | PDF ↗ |
| K181174 | Cardinal Health Sterilization Wrap | Cardinal Health200, LLC | 2018-12-11 | Traditional | PDF ↗ |
| K172280 | BH Sterilization Pouch | Bh Medical Products Co., Ltd. | 2018-08-03 | Traditional | PDF ↗ |
| K180672 | Sterilization Pouch/Roll Made with Tyvek | Sigma Medical Supplies Corporation | 2018-06-06 | Abbreviated | PDF ↗ |
| K180661 | SIGMA Sterilization Pouch and Roll | Sigma Medical Supplies Corp. | 2018-06-05 | Abbreviated | PDF ↗ |
| K172749 | Vis-U-All Low Temperature Sterilization Pouch/Tubing | STERIS Corporation | 2018-02-09 | Traditional | PDF ↗ |
| K170437 | Sterisheet Sterilization Wrap | Andersen Sterilizers, Inc. | 2017-11-01 | Traditional | PDF ↗ |
| K170429 | Tyvek Sterilization Pouches with Chevron Seal | Andersen Sterilizers, Inc. | 2017-10-27 | Traditional | PDF ↗ |
| K162362 | PMSSteripack Flat Sterilization Pouch (FP) and Roll (FL) with Chemical Indicator | Pms Tibbi Cihazlar Teknolojisi San VE Tic AS | 2017-10-13 | Traditional | PDF ↗ |
| K172207 | Standard Supreme Sterilization Wrapper | Standard Textile Co., Inc. | 2017-08-25 | Traditional | PDF ↗ |
| K171533 | Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap | Ahlstrom Nonwovens, LLC | 2017-06-29 | Traditional | PDF ↗ |
| K162993 | Gemini Sterilization Wrap | Medline Industries, Inc. | 2017-06-23 | Traditional | PDF ↗ |
| K162258 | Self Sealing Sterilization Pouches | Tianchang Jiarui Packaging Material Co., Ltd. | 2017-04-28 | Traditional | PDF ↗ |
| K161910 | Cardinal Health Sterilization Wrap | Cardinal Health200, LLC | 2017-04-20 | Traditional | PDF ↗ |
| K161415 | SteriTite Containers System & MediTray Products | Case Medical, Inc. | 2017-02-10 | Traditional | PDF ↗ |
| K160595 | PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical Indicator | Pms Medikal Ambalaj Sanayi VE Ticaret Ltd Sti | 2016-11-18 | Traditional | PDF ↗ |
| K162162 | Barrier Supreme Sterilization Wrapper | Standard Textile Co., Inc. | 2016-11-04 | Traditional | PDF ↗ |
| K153540 | Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators | Safe Secure Packaging Co., Ltd. | 2016-08-04 | Traditional | PDF ↗ |
| K160755 | Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap | Ahlstrom Nonwovens, LLC | 2016-07-27 | Traditional | PDF ↗ |
| K160908 | Vis-U-All Low Temperature Sterilization Pouch/Tubing | STERIS Corporation | 2016-07-22 | Traditional | PDF ↗ |
| K152564 | Gemini Sterilization Wrap | Medline Industries, Inc. | 2016-07-07 | Traditional | PDF ↗ |
| K152458 | Gemini Bonded Sterilization Wrap | Medline Industries, Inc. | 2016-06-01 | Traditional | PDF ↗ |
| K152669 | PMSSteripack Self-Seal Sterilization Pouch with Chemical Indicator (KP) | Pms Tip Teknolojileri Sanayi VE Ticaret Limited Std | 2016-01-15 | Traditional | PDF ↗ |
| K153025 | Turbett Surgical Container | Turbett Surgical, LLC | 2016-01-14 | Traditional | PDF ↗ |
| K151445 | Cardinal Health Sterilization Wrap | Cardinal Health200, LLC | 2015-12-21 | Traditional | PDF ↗ |
| K152291 | Sterisheet Sterilization Wrap | Andersen Sterilizers, Inc. | 2015-12-17 | Traditional | PDF ↗ |
| K150698 | Gemini Sterilization Wrap | Medline Industries, Inc. | 2015-11-20 | Traditional | PDF ↗ |
| K152058 | Tyvek Sterilization Pouches with Chevron Seal | Andersen Sterilizers, Inc. | 2015-11-18 | Traditional | PDF ↗ |
| K151788 | Cardinal Health Sterilization Wrap | Cardinal Health200, LLC | 2015-10-30 | Traditional | PDF ↗ |
| K143117 | Wire Sterilization Package with Indicators | American Orthodontics | 2015-10-29 | Traditional | PDF ↗ |
| K143637 | U&U Sterilization Pouch and Roll | U&U Medical Technology Co, Ltd. | 2015-09-09 | Traditional | PDF ↗ |
| K143147 | Gemini Bonded Sterilization Wrap | Medline Industries, Inc. | 2015-05-07 | Special | PDF ↗ |
| K143053 | KIMGUARD ONE-STEP Sterilization Wrap | Kimberly-Clark Health Care | 2015-04-03 | Traditional | PDF ↗ |
| K141826 | FLASHPAK STERILIZATION CONTAINER SYSTEM | Symmetry Medical Inc- Manchester | 2015-04-02 | Traditional | PDF ↗ |
| K133838 | STERILIZATION POUCH/ROLL MADE WITH TYVEK | Sigma Medical Supplies Corp. | 2015-03-11 | Traditional | PDF ↗ |
| K142782 | KIMGUARD ONE-STEP Sterilization Wrap | Kimberly-Clark Health Care | 2015-03-09 | Traditional | PDF ↗ |
| K141693 | Tyvek® Pouch/Roll with STERRAD® Chemical Indicator | Advanced Sterilization Products | 2014-12-19 | Traditional | PDF ↗ |
| K141712 | KIMGUARD ONE STEP STERILIZATION WRAP | Halyard Health | 2014-12-18 | Traditional | PDF ↗ |
| K141412 | STERILUCENT SELF-SEAL STERILIZATION POUCH | Gs Medical Packaging, Inc. | 2014-12-03 | Traditional | PDF ↗ |
| K140963 | KIMGUARD SMART-FOLD STERILIZATION WRAP | Kimberly-Clark Corp. | 2014-11-10 | Traditional | PDF ↗ |
| K141612 | KIMGUARD ONE-STEP STERILIZATION WRAP | Kimberly-Clark Health Care | 2014-08-07 | Special | PDF ↗ |
Product code FRG · Class II · General Hospital. Data: openFDA.