Peeps
Antibacterial Bandages, assorted sizes, 3/4'' Strips, .75 IN x 3 IN (19 mm x 76 mm), 5/8'' Strips, 0.62 IN X 2.25 IN (15 mm X 57 mm)
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 | 2023-12-25 |
| Record revised | 2023-09-22 (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 72 |
| Distribution end date | 2022-02-12 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 017276239812 | 20 | In distribution | |
| 017276238563 | 14 | Withdrawn | |
| 017276237276 | 14 | Withdrawn |
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.