Data / Medical devices / Strip, Adhesive, Closure, Skin
Strip, Adhesive, Closure, Skin (FPX): 20 FDA-registered makers in 6 countries
20 establishments in 6 countries are registered with the FDA to make Strip, Adhesive, Closure, Skin (product code FPX, Class 1, 21 CFR 880.5240). 4 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 35 510(k) clearances under this code, the latest on May 9, 1997, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- FPX
- Device class
- 1
- Regulation
- 880.5240
- Medical specialty
- General Hospital
Makers by country
| Country | Makers |
|---|---|
| China | 13 |
| United States | 3 |
| Canada | 1 |
| Australia | 1 |
| Taiwan | 1 |
| Egypt | 1 |
Makers of Strip, Adhesive, Closure, Skin
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Aspen Surgical Products, Inc. | Caledonia, MI, United States | Manufacturer | 1 | January 29, 1988 | 0 | 1 | 0 | api.fda.gov |
| Derma Sciences Canada, Inc | TORONTO Ontario, Canada | Manufacturer | 1 | July 25, 1989 | 0 | 0 | 0 | api.fda.gov |
| Dukal LLC | Ronkonkoma, NY, United States | Complaint file establishment, Specification developer | 1 | July 14, 1993 | 0 | 0 | 0 | api.fda.gov |
| Rfx+care Manufacturing Co., Ltd. | Shaoxing Zhejiang, China | Exporter to the US, Manufacturer, Repackager or relabeler | 1 | July 14, 1993 | 0 | 0 | 0 | api.fda.gov |
| Boen Healthcare Co., Ltd. | Suzhou Jiangsu, China | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Derma Sciences Nantong Incorporation | DEVELOPMENT Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| HongYu BioTech (ShenZhen) Co., Ltd | Shenzhen Guangdong, China | Contract manufacturer, Exporter to the US | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Qiantai Medical Instrument Co., Ltd. | Tai zhou Jiangsu, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jinhua Jingdi Medical Supplies Co.,ltd | Jinhua Zhejiang, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiujiang Jiebao Medicine Equipment Co., Ltd | Jiujiang City Jiangxi, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nutricare Pty Ltd | Melbourne Victoria, Australia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Openpatch Inc. | Taipei, Taiwan | Complaint file establishment, Contract manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pharmaplast S.A.E. | ALEXANDRIA Al Iskandariyah, Egypt | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Qidong Farjoy Medical Material Co., Ltd. | Qidong Jiangsu, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ready Set Import | Beverly Hills, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yafho Bio-Technology Co., Ltd. | GUANGZHOU Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yiwu Haoding Medical Co.,ltd | Yiwu Zhejiang, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Hangbiao Medical Products Co.,ltd | Jinhua Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Haomep Medical Products Co.,ltd | YIWU Zhejiang, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Longterm Medical Technology Co., LTD | Huzhou City Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated May 9, 1997. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.