High Strength Pressure Bandage
High Strength Pressure Bandage, 6", Tourniquet
280manufacturers in China registered for this device type
2catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Jiangsu (85), Zhejiang (75), Guangdong (29). 38 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Shanghai Joy Crown Industry Co., Ltd. | Pu Dong New Area | Shanghai | Contract manufacturer | 64 |
| Suzhou Pipi Medical Products Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 48 |
| Hubei V-Medical Products Co., Ltd. | Xiantao | Hubei | Contract manufacturer | 46 |
| Allmed Medical Products Co., Ltd. | Zhijiang | Hubei | Contract manufacturer | 43 |
| Shanghai Leison Medical & Healthcare Products Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 32 |
| Planet (Anhui) Medical Products Co., Ltd. | Chuzhou | Anhui | Contract manufacturer | 30 |
| Jiangsu Huadong Medical Device Industry Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 29 |
| Zhongshan Chukuang Textile Co., Ltd. | Zhongshan | Guangdong | Contract manufacturer | 26 |
| Nanjing 3H Medical Products Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 25 |
| Jingmen Huasheng Asia Dynamics Sanitary Products Co., Ltd. | Jingmen | Hubei | Contract manufacturer | 23 |
| Lingxian Dongsheng Textile Co., Ltd. | Dezhou | Shandong | Contract manufacturer | 23 |
Showing 12 of 280. All 280 manufacturers in China registered for Bandage, Elastic
Record
| Listed by | Dynarex Corp., United States |
|---|---|
| FDA product code | FQM |
| Device type | Bandage, Elastic |
| Device class | Class 1 |
| Regulation | 21 CFR 880.5075 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-06-21 |
| Record revised | 2026-03-23 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Case of 50, case of 100 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3684 | In distribution | |
| 3683 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DeRoyal | Deroyal Industries, Inc. | 194 |
| MT Spandage | Medi-Tech, Inc. | 107 |
| Tronex International, Inc. | Tronex International, Inc. | 79 |
| Bioseal Inc. | Bioseal | 57 |
| Medline | Medline Industries, Inc. | 56 |
| 3M™ Coban™ | 3M Company | 52 |
| Sensi-Wrap, Self Adherent | Dynarex Corp. | 49 |
| Cardinal Health | Cardinal Health 200, LLC | 49 |
| Bandage, Elastic | Tetra Medical Supply Corp. | 48 |
| PremierPro | Prestige Ameritech | 48 |
| Co-Ease | Hemasource | 45 |
| CotZee | Hemasource | 44 |
Showing 12 of 345. All products under Bandage, Elastic
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2004-05-10 | Not classified | Other | Bandages labeled as “100% Latex Free” may contain latex. The wrapper was analytically tested by a private laboratory and found to contain latex. | 50 cases (Lot 15860); 166 cases (lots 15901, 15706) | 2012-08-30 |
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.