The following data is part of a premarket notification filed by Primus Gloves Private Ltd. with the FDA for Pre-powdered Latex Orthopedic Surgeon's Gloves.
| Device ID | K030444 |
| 510k Number | K030444 |
| Device Name: | PRE-POWDERED LATEX ORTHOPEDIC SURGEON'S GLOVES |
| Classification | Surgeon's Gloves |
| Applicant | PRIMUS GLOVES PRIVATE LTD. PLOT NO:14-A COCHIN SPECIAL ECONOMIC ZONE Kakkanad, Kochi, Kerala, IN 682 030 |
| Contact | Joseph J.e. Pereira |
| Correspondent | Joseph J.e. Pereira PRIMUS GLOVES PRIVATE LTD. PLOT NO:14-A COCHIN SPECIAL ECONOMIC ZONE Kakkanad, Kochi, Kerala, IN 682 030 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-11 |
| Decision Date | 2003-06-05 |