3m™ Steri-Strip™
3M™ Steri-Strip™ Reinforced Adhesive Skin Closures Non-Sterile, R1541NS,Bulk 3000 Strips, 1/4IN x 3IN, 3 Strip/Card, 1000 Card/CS
353manufacturers in China registered for this device type
59catalogue numbers in this listing
6510(k) clearances naming this product code
11recalls on this 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 | 3M Company, 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 | 2021-03-08 |
| Record revised | 2023-02-20 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Box of 4, case of 50, case of 4, case of 500 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| E4541 | 3 | In distribution | |
| R1546 | 50 | In distribution | |
| E4542 | 50 | In distribution | |
| B1551 | 50 | In distribution | |
| A1841 | 50 | In distribution | |
| W8516 | 25 | In distribution | |
| E4547 | 50 | In distribution | |
| A1842 | 50 | In distribution | |
| R1540 | 5 | In distribution | |
| C1544 | 40 | In distribution | |
| R1540 | 50 | In distribution | |
| E4549 | 50 | In distribution | |
| E4546 | 50 | In distribution | |
| R1541NS | 1,000 | In distribution | |
| A1846 | 50 | In distribution | |
| R1548NS | 1,000 | In distribution | |
| R1541 | 3 | In distribution | |
| R1540SB | 5 | In distribution | |
| E4541 | 50 | In distribution | |
| R1542SB | 6 | In distribution | |
| R1549 | 6 | In distribution | |
| B1553 | 50 | In distribution | |
| A1847 | 50 | In distribution | |
| E4548 | 4 | In distribution | |
| R1547 | 6 | In distribution | |
| R1548 | 25 | In distribution | |
| C1544 | 40 | In distribution | |
| R1542 | 50 | In distribution | |
| E4548 | 25 | In distribution | |
| R1547NS | 1,000 | In distribution | |
| E4540 | 50 | In distribution | |
| W8514 | 25 | In distribution | |
| R1549 | 50 | In distribution | |
| R1546 | 10 | In distribution | |
| W8512 | 25 | In distribution | |
| R1542 | 6 | In distribution | |
| B1557 | 50 | In distribution | |
| B1550 | 50 | In distribution | |
| W8516 | 25 | In distribution | |
| B1559 | 50 | In distribution | |
| E4549 | 6 | In distribution | |
| A1848 | 25 | In distribution | |
| R1541SB | 3 | In distribution | |
| W8516 | 25 | In distribution | |
| A1840 | 50 | In distribution | |
| R1546SB | 10 | In distribution | |
| R1541 | 50 | In distribution | |
| W8512 | In distribution | ||
| R1547SB | 6 | In distribution | |
| W8514 | 25 | In distribution | |
| R1547 | 50 | In distribution | |
| B1557 | 6 | In distribution | |
| E4542 | 6 | In distribution | |
| T1545NS | 1,000 | In distribution | |
| E4547 | 6 | In distribution | |
| B1551 | 3 | In distribution | |
| B1559 | 6 | In distribution | |
| R1546NS | 1,000 | In distribution | |
| R1548 | 4 | 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™ Medipore™ | 3M Company | 58 |
| DeRoyal | Deroyal Industries, Inc. | 56 |
Showing 12 of 966. All products under Tape And Bandage, Adhesive
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K901777 | 1990-08-08 |
| K901845 | 1990-07-23 |
| K813265 | 1983-02-09 |
| K811291 | 1981-06-02 |
| K810580 | 1981-03-20 |
| K802242 | 1980-09-26 |
Recalls
3 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 |
|---|---|---|---|---|---|
| 2024-03-20 | Class II | Error in labeling | Select lots of the 3M Durapore Surgical Tape, Catalog Number 1538-118, were incorrectly labeled with a shelf life of 5 years, rather than 3 years. | 3,515,200 rolls | |
| 2024-02-20 | Class II | Process control | Manufacturing nonconformities are in some lots of the Tube Securement Device, such as the top film layer may be partially or completely missing and some devices may exhibit the appearance of an incorrect shape due to excess material not bei | 265,435 eaches | |
| 2019-11-21 | Class II | Device Design | While the product meets all safety and efficacy criteria, long term exposure of 3M Durapore Advanced Surgical Tape to continuous high moisture clinical applications has not fully met all of 3M s performance expectations. This use environmen | 470,954 rolls | 2021-04-23 |
| 2010-01-29 | Not classified | Nonconforming Material/Component | Reduced adhesion: Micropore Surgical Tape for use as the primary securement device for 1) dialysis needles used to access A-V fistulas or grafts; or 2) pressure dressings used after dialysis treatments. If the tape does not perform, the di | 2,664,800 | 2012-02-04 |
| 2010-01-29 | Not classified | Nonconforming Material/Component | Reduced adhesion: Micropore Surgical Tape for use as the primary securement device for 1) dialysis needles used to access A-V fistulas or grafts; or 2) pressure dressings used after dialysis treatments. If the tape does not perform, the di | 4851 rolls | 2012-02-04 |
| 2010-01-29 | Not classified | Nonconforming Material/Component | Reduced adhesion: Micropore Surgical Tape for use as the primary securement device for 1) dialysis needles used to access A-V fistulas or grafts; or 2) pressure dressings used after dialysis treatments. If the tape does not perform, the di | 15,360 rolls | 2012-02-04 |
| 2010-01-29 | Not classified | Nonconforming Material/Component | Reduced adhesion: Micropore Surgical Tape for use as the primary securement device for 1) dialysis needles used to access A-V fistulas or grafts; or 2) pressure dressings used after dialysis treatments. If the tape does not perform, the di | 499,200 | 2012-02-04 |
| 2010-01-29 | Not classified | Nonconforming Material/Component | Reduced adhesion: Micropore Surgical Tape for use as the primary securement device for 1) dialysis needles used to access A-V fistulas or grafts; or 2) pressure dressings used after dialysis treatments. If the tape does not perform, the di | 132,420 rolls | 2012-02-04 |
| 2010-01-29 | Not classified | Nonconforming Material/Component | Reduced adhesion: Micropore Surgical Tape for use as the primary securement device for 1) dialysis needles used to access A-V fistulas or grafts; or 2) pressure dressings used after dialysis treatments. If the tape does not perform, the di | 525,600 rolls | 2012-02-04 |
| 2010-01-29 | Not classified | Nonconforming Material/Component | Reduced adhesion: Micropore Surgical Tape for use as the primary securement device for 1) dialysis needles used to access A-V fistulas or grafts; or 2) pressure dressings used after dialysis treatments. If the tape does not perform, the di | 20,400 | 2012-02-04 |
| 2010-01-29 | Not classified | Nonconforming Material/Component | Reduced adhesion: Micropore Surgical Tape for use as the primary securement device for 1) dialysis needles used to access A-V fistulas or grafts; or 2) pressure dressings used after dialysis treatments. If the tape does not perform, the di | 165,826 boxes, 100 rolls per box (16,582,600 rolls) | 2012-02-04 |
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.