Data / Medical devices / India / Primus Gloves Private Ltd.
Primus Gloves Private Ltd.: FDA-registered device maker in Kakkanad, Cochin, Kerala, India, 13 510(k) clearances
Primus Gloves Private Ltd. is registered with the FDA (registration 3003529075) in Kakkanad, Cochin, Kerala, India. It lists 4 device types. The FDA files 13 510(k) clearances under its listings, the newest dated October 23, 2017. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3003529075
- Address
- 14-A, Cochin Special Economic Zone, Kakkanad, Cochin, Kerala, India, 682037
- Owner or operator
- PRIMUS GLOVES PRIVATE LIMITED (9039301)
- Roles
- Manufacturer, Specification developer
- First device listed
- November 28, 2007
- Registered through
- 2027
- Brand names listed
- DYNAREX, INVAGEN, JORDAN CONSULTING GROUP, RAIVANSA, SHIELD LINE
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Latex Patient Examination Glove | LYY | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Surgeon'S Gloves | KGO | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Vinyl Patient Examination Glove | LYZ | 1 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| October 23, 2017 | K170612 | STERILE VINYL EXAMINATION GLOVES, Powder Free | LYZ | Substantially Equivalent | Primus Gloves Pvt Limited | accessdata.fda.gov |
| June 9, 2017 | K170515 | Sterile Nitrile Surgical Gloves, Powder-free | KGO | Substantially Equivalent | Primus Gloves Pvt Limited | accessdata.fda.gov |
| April 14, 2016 | K143477 | Nitrile Patient Examination gloves, Powderfree, Blue color | LZA | Substantially Equivalent | Primus Gloves Pvt Limited | accessdata.fda.gov |
| June 5, 2003 | K030445 | POWDER FREE LATEX MICROSURGERY GLOVES WITH BROWN COLOR AND PROTEIN LABELING CLAIM OF 50 MICROGRAMS OR LESS PROTEIN GRAM | KGO | Substantially Equivalent | Primus Gloves Private , Ltd. | accessdata.fda.gov |
| June 5, 2003 | K030444 | PRE-POWDERED LATEX ORTHOPEDIC SURGEON'S GLOVES | KGO | Substantially Equivalent | Primus Gloves Private , Ltd. | accessdata.fda.gov |
| May 8, 2002 | K021065 | PRE-POWDERED STERILE SURGEON'S GLOVES (WITH A 50 MICROGRAM/GM PROTEIN CLAIM | KGO | Substantially Equivalent | Primus Gloves Private , Ltd. | accessdata.fda.gov |
| February 26, 2002 | K020044 | VINYL EXAMINATION GLOVES STERILE POWEDERED | LYZ | Substantially Equivalent | Primus Gloves Private , Ltd. | accessdata.fda.gov |
| July 5, 2000 | K001715 | POWDERED PATIENT EXAMINATION GLOVES, LATEX | LYY | Substantially Equivalent | Fitco Dipped Products Pvt., Ltd. | accessdata.fda.gov |
| May 15, 2000 | K001232 | NON-STERILE POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM 50 MICROGRAMS OR LESS | LYY | Substantially Equivalent | Fitco Dipped Products Pvt., Ltd. | accessdata.fda.gov |
| May 3, 2000 | K000896 | POWDERFREE LATEX SURGEON'S GLOVES WITH PROTIEN LABELING CLAIM (50 MOCROGRAMS OR LESS | KGO | Substantially Equivalent | Fitco Dipped Products Pvt., Ltd. | accessdata.fda.gov |
| April 28, 2000 | K001216 | POWDER-FREE LATEX EXAMINATION GLOVE STERILE WITH OPTIONAL PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) | LYY | Substantially Equivalent | Fitco Dipped Products Pvt., Ltd. | accessdata.fda.gov |
| April 28, 2000 | K000891 | STERILE LATEX POWDERED PATIENT EXAMINATION GLOVES | LYY | Substantially Equivalent | Fitco Dipped Products Pvt., Ltd. | accessdata.fda.gov |
| December 29, 1999 | K993450 | LATEX SURGICAL GLOVES, PRE-POWDERED | KGO | Substantially Equivalent | Fitco Dipped Products Pvt., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Surgeon'S Gloves
- All makers of Vinyl Patient Examination Glove
- All makers of Latex Patient Examination Glove
- All makers of Polymer Patient Examination Glove
Updated October 23, 2017. 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.