Rudolph
Catalogue number 017276235616, listed by ASO LLC, United States, under Tape And Bandage, Adhesive. 353 manufacturers in China are registered for this product code.
Who Else Makes It
Concentrated in Zhejiang (101), Jiangsu (84), Guangdong (47). 40 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 |
| Taizhou Xinkang Medical Materials Co., Ltd. | Taizhou | Jiangsu | Contract manufacturer | 35 |
| Zhejiang Anji Huabu Industrial Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 32 |
| Shanghai Care Us Medical Product Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 30 |
| Jinhua Jingdi Medical Supplies Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 29 |
| Nanjing 3H Medical Products Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 25 |
| Anji Hengfeng Sanitary Material Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 20 |
| Changzhou Recoo Healthcare Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 19 |
| Henso Medical (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 19 |
| Huizhou Foryou Medical Devices Co., Ltd. | Huizhou | Guangdong | Contract manufacturer | 18 |
| Jianerkang Medical Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 18 |
Showing 12 of 353. All 353 manufacturers in China registered for Tape And Bandage, Adhesive
Record
| Listed by | ASO LLC, United States |
|---|---|
| FDA product code | KGX |
| Device type | Tape And Bandage, Adhesive |
| Device class | Class 1 |
| Regulation | 21 CFR 880.5240 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-09-27 |
| Record revised | 2023-06-27 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
| Packaging | Case of 12 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 017276235616 | 20 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Curad | Medline Industries, Inc. | 174 |
| First Aid Only | Acme United Corp. | 130 |
| CVS Health | Woonsocket Prescription Center, Incorporated | 120 |
| American White Cross | Dukal LLC | 120 |
| Avaline Medical NJ LLC | Avaline Medical NJ Limited Liability Company | 119 |
| Howsport | Jiaxing HOW Sport Medical Instrument Co., Ltd. | 109 |
| Endure | Endure Industries, Inc. | 71 |
| TheraBand Kinesiology Tape | Hygenic Corporation, THE | 71 |
| Dukal | Dukal LLC | 68 |
| McKesson | Mckesson Medical-Surgical Inc. | 64 |
| 3M™ Steri-Strip™ | 3M Company | 59 |
| 3M™ Medipore™ | 3M Company | 58 |
Showing 12 of 966. All products under Tape And Bandage, Adhesive
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K983368 | 1999-02-17 |
| K932602 | 1993-08-09 |
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2023-03-23 | Class II | Process design | The adhesive bandage contains 0.1% benzalkonium chloride impregnated in the pad and is not disclosed on the labeling. | 919 cases of 24 units | |
| 2015-06-10 | Class II | Process control | Contain 0.1% Benzalkonium Chloride in the 5/8 bandages inside the assortment which is not listed as an active ingredient in the product label. | 655 cases. | 2016-10-12 |
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.