Data / Medical devices / Drape, Pure Latex Sheet, With Self-Retaining Finger Cot
Drape, Pure Latex Sheet, With Self-Retaining Finger Cot (EYX): 5 FDA-registered makers in 4 countries
5 establishments in 4 countries are registered with the FDA to make Drape, Pure Latex Sheet, With Self-Retaining Finger Cot (product code EYX, Class 2, 21 CFR 878.4370). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 1 510(k) clearance under this code, the latest on August 30, 1976, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- EYX
- Device class
- 2
- Regulation
- 878.4370
- Medical specialty
- General, Plastic Surgery
Makers by country
| Country | Makers |
|---|---|
| China | 2 |
| United States | 1 |
| India | 1 |
| Vietnam | 1 |
Makers of Drape, Pure Latex Sheet, With Self-Retaining Finger Cot
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 |
|---|---|---|---|---|---|---|---|---|
| Cardinal Health | Hazelwood, MO, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan Shin Yi Healthcare Products Factory | DONG GUAN CITY Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hospital Equipment MFG. Co. | NOIDA Uttar Pradesh, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Medplus Non-Woven Manufacturer Co.,ltd. | Siyang Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Quang Nam Medical Devices Factory Branch Of Danameco Medical Joint Stock Corporation | Dien Ban Bac Ward Da Nang, Vietnam | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated August 30, 1976. 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.