Data / Medical devices / Taiwan / Formosa Glove Industrial Co., Ltd.
Formosa Glove Industrial Co., Ltd.: FDA-registered device maker in Tainan, Taiwan, 2 510(k) clearances
Formosa Glove Industrial Co., Ltd. is registered with the FDA (registration 9616896) in Tainan, Taiwan. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated February 15, 2002. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9616896
- FEI number
- 3003346215
- Address
- No. 251, Mayou 1st Rd., Madou Dist., Tainan, Taiwan, 721013
- Owner or operator
- FORMOSA GLOVE INDUSTRIAL CO., LTD. (9034492)
- Roles
- Manufacturer
- First device listed
- December 17, 2007
- Registered through
- 2026
- Brand names listed
- Nitrile Patient Examination Glove, Nitrile Patient Examination Gloves,
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Polymer Patient Examination Glove | LZA | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 15, 2002 | K014284 | NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE AND YELLOWISH WHITE | LZA | Substantially Equivalent | Formosa Glove Industrial Co., Ltd. | accessdata.fda.gov |
| September 10, 1999 | K992588 | BLUE NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE | LZA | Substantially Equivalent | Formosa Glove Industrial Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated February 15, 2002. 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.