The following data is part of a premarket notification filed by Primus Gloves Private Ltd. with the FDA for Powder Free Latex Microsurgery Gloves With Brown Color And Protein Labeling Claim Of 50 Micrograms Or Less Protein Gram.
| Device ID | K030445 |
| 510k Number | K030445 |
| Device Name: | POWDER FREE LATEX MICROSURGERY GLOVES WITH BROWN COLOR AND PROTEIN LABELING CLAIM OF 50 MICROGRAMS OR LESS PROTEIN GRAM |
| Classification | Surgeon's Gloves |
| Applicant | PRIMUS GLOVES PRIVATE LTD. 14-A, COCHIN SPECIAL ECONOMIC ZONE Kakkanad, Cochin, Kerala, IN 682037 |
| Contact | Joseph J.e. Pereira |
| Correspondent | Joseph J.e. Pereira PRIMUS GLOVES PRIVATE LTD. 14-A, COCHIN SPECIAL ECONOMIC ZONE Kakkanad, Cochin, Kerala, IN 682037 |
| 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 |