Standard Supreme Wrapper
Standard Supreme Wrapper is a reusable textile wrap for enclosing medical devices before sterilization and maintaining their sterility until use. It is woven from blended cotton and…
Standard Supreme Wrapper is a reusable textile wrap for enclosing medical devices before sterilization and maintaining their sterility until use. It is woven from blended cotton and polyester yarns and supplied in misty, ceil and jade colors. The wrappers are distributed nonsterile for processing by healthcare or laundry facilities.
The range includes square and rectangular sizes. The jade 23 by 23 inch wrapper is one listed configuration. Oblong and envelope folds are validated for textile packs, with closure options including autoclave tape and elastomer closures as part of established wrapping procedures.
Listed Item
Wrapper Standard Supreme Kaum 23X23 Jade 2PLY – RM (98 8281) USE: 21532002
Processing Limits
The wrappers are reusable through 75 wash, dry and sterilization cycles. Validation used sequential double wrapping of textile packs and a prevacuum steam cycle with four minutes of exposure at 270 degrees Fahrenheit. The validated maximum pack volume was 0.58 cubic feet at 12.9 pounds.
Who Else Makes It
Concentrated in Jiangsu (9), Guangdong (9), Shanghai (5). 17 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Tribest Dental Products Co Ltd | Yangzhong | Jiangsu | Contract manufacturer | 58 |
| Hubei Qianjiang Kingphar Medical Material Co., Ltd. | Qianjiang | Hubei | Contract manufacturer | 52 |
| Principle & Will Biotech (Pinghu) Co., Ltd. | Pinghu | Zhejiang | Contract manufacturer | 39 |
| Dongguan Shin YI Healthcare Products Factory | Dong Guan | Guangdong | Contract manufacturer | 30 |
| Anhui Ares Medical Technology Co., Ltd. | Tianchang | Anhui | Contract manufacturer | 28 |
| Wuhan Zonsen Medical Products Co., Ltd. | Wuhan | Hubei | Contract manufacturer | 24 |
| Sino Protection (Hefei) Medical Products Co., Ltd. | Hefei | Anhui | Contract manufacturer | 18 |
| Exact Medical Manufacturing, Inc. | Changzhou | Jiangsu | Contract manufacturer | 17 |
| Lianyungang Bronson Non-woven Products Co., Ltd. | Lianyungang | Jiangsu | Contract manufacturer | 16 |
| Foshan Nanhai Plus Medical Co Ltd | Foshan | Guangdong | Contract manufacturer | 12 |
| Primed Liyang Medical Products Manufacturing Co., Ltd. | Liyang | Jiangsu | Contract manufacturer | 11 |
| Binzhou Dingyue Clothing Company Limited | Binzhou | Shandong | Contract manufacturer | 7 |
Showing 12 of 38. All 38 manufacturers in China registered for Wrap, Sterilization
Record
| Listed by | Standard Textile Co., Inc., United States |
|---|---|
| FDA product code | FRG |
| Device type | Wrap, Sterilization |
| Device class | Class 2 |
| Regulation | 21 CFR 880.6850 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K172207 |
| Record published | 2018-01-29 |
| Record revised | 2023-06-30 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Over the counter | Yes |
| Label carries | lot or batch number |
| Distribution end date | 2025-11-18 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 215U6402 | 144 | In distribution | |
| 21543002 | 72 | In distribution | |
| 21548202 | 36 | In distribution | |
| 21530812 | 36 | In distribution | |
| 21538802 | 36 | In distribution | |
| 21532802 | 72 | In distribution | |
| 215U5902 | 72 | In distribution | |
| 21542002 | 144 | In distribution | |
| 215U9502 | 36 | In distribution | |
| 21532002 | 144 | In distribution | |
| 96500332 | 36 | In distribution | |
| 21523002 | 72 | In distribution | |
| 21526002 | 36 | In distribution | |
| 21531502 | 144 | In distribution | |
| 21530812 | 36 | In distribution | |
| 21521502 | 144 | In distribution | |
| 96500342 | 36 | In distribution | |
| 21542802 | 72 | In distribution | |
| 21528802 | 36 | In distribution | |
| 21533002 | 72 | In distribution | |
| 21538202 | 36 | In distribution | |
| 21548802 | 36 | In distribution | |
| 21536002 | 36 | In distribution | |
| 21522002 | 144 | In distribution | |
| 21522802 | 72 | In distribution | |
| 21545002 | 72 | In distribution | |
| 21528202 | 36 | In distribution | |
| 21525002 | 72 | In distribution | |
| 21535002 | 72 | In distribution | |
| 21546002 | 36 | In distribution | |
| 215W0802 | 72 | In distribution | |
| 96543422 | 144 | Withdrawn | |
| 2154514G | 72 | Withdrawn | |
| 215W4002 | 36 | Withdrawn | |
| 21533M26 | 72 | Withdrawn | |
| 21541502 | 144 | Withdrawn | |
| 21548EH7 | 36 | Withdrawn | |
| 215350H5 | 72 | Withdrawn | |
| 215W2102 | 36 | Withdrawn | |
| 21532302 | 144 | Withdrawn | |
| 21543EH7 | 72 | Withdrawn | |
| 215E7002 | 36 | Withdrawn | |
| 215F4802 | 36 | Withdrawn | |
| 95301183 | 72 | Withdrawn | |
| 215330H5 | 72 | Withdrawn | |
| 21532M14 | 144 | Withdrawn | |
| 215D2902 | 36 | Withdrawn | |
| 215H1302 | 36 | Withdrawn | |
| 95596852 | 72 | Withdrawn | |
| 21545EH7 | 72 | Withdrawn | |
| 215K6202 | 36 | Withdrawn | |
| 96543412 | 144 | Withdrawn | |
| 96500623 | 36 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medline | Medline Industries, Inc. | 824 |
| Cardinal Health | Cardinal Health 200, LLC | 333 |
| Arjo Wiggins Medical, Inc. | Sterimed, Inc. | 286 |
| Halyard | O&M Halyard, Inc. | 191 |
| Primed | Primed Medical Products Inc. | 154 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 148 |
| Vivit Supply | Vivit Supply LLC | 103 |
| Case Medical | Case Medical, Inc. | 103 |
| Gemini | Medline Industries, Inc. | 89 |
| CareGUARD | Care Essentials PTY Ltd | 72 |
| Halyard | Owens & Minor Distribution, Inc. | 70 |
| Wrap, Sterilization | Steris Corporation | 69 |
Showing 12 of 232. All products under Wrap, Sterilization
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K172207 | 2017-08-25 |
| K162162 | 2016-11-04 |
| K923408 | 1993-04-08 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.