Data / Medical devices / India / Kanam Latex Industries Pvt. Ltd.
Kanam Latex Industries Pvt. Ltd.: FDA-registered device maker in NAGERCOIL Tamil Nadu, India, 4 510(k) clearances
Kanam Latex Industries Pvt. Ltd. is registered with the FDA (registration 3004967282) in NAGERCOIL Tamil Nadu, India. It lists 2 device types. The FDA files 4 510(k) clearances under its listings, the newest dated September 13, 2005. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3004967282
- Address
- 12-67C, Anandanadarkudy P.O. Vembanoor, NAGERCOIL Tamil Nadu, India, 629201
- Owner or operator
- KANAM LATEX INDUSTRIES PVT. LTD. (8040980)
- Roles
- Contract manufacturer, Contract sterilizer, Manufacturer, Remanufacturer, Repackager or relabeler
- First device listed
- November 4, 2005
- Registered through
- 2026
- Brand names listed
- KALTEX, SURGICARE, SURGICARE NEOPRENE, SURGICARE PREMIER, The Double¿ Glove
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Latex Patient Examination Glove | LYY | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Surgeon'S Gloves | KGO | 1 | Contract manufacturer, Contract sterilizer, Manufacturer, Remanufacturer, Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| September 13, 2005 | K052214 | PRE-POWDERED STERILE EXAM GLOVES | LYY | Substantially Equivalent | Kanam Latex Industries Pvt. , Ltd. | accessdata.fda.gov |
| March 14, 2003 | K030228 | POWDERFREE POLYCHLOROPRENE STERILIZED SURGICAL GLOVES | KGO | Substantially Equivalent | Pt. Medisafe Technologies | accessdata.fda.gov |
| January 31, 1991 | K904972 | SURGICARE STERILE SURGICAL GLOVES | KGO | Substantially Equivalent | Kanam Latex Industries Pvt. , Ltd. | accessdata.fda.gov |
| January 23, 1990 | K897139 | LATEX PATIENT EXAMINATION GLOVES | LYY | Substantially Equivalent | Kanam Latex Industries Pvt. , Ltd. | accessdata.fda.gov |
Compare with other makers
Updated September 13, 2005. 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.