The following data is part of a premarket notification filed by Primus Gloves Private Ltd. with the FDA for Pre-powdered Sterile Surgeon's Gloves (with A 50 Microgram/gm Protein Claim.
| Device ID | K021065 |
| 510k Number | K021065 |
| Device Name: | PRE-POWDERED STERILE SURGEON'S GLOVES (WITH A 50 MICROGRAM/GM PROTEIN CLAIM |
| Classification | Surgeon's Gloves |
| Applicant | PRIMUS GLOVES PRIVATE LTD. 14 A, COCHIN SPECIAL ECONOMIC ZONE Kakkanad, Cochin, Kerala, IN 682 030 |
| Contact | Joseph J E Pereira |
| Correspondent | Joseph J E Pereira PRIMUS GLOVES PRIVATE LTD. 14 A, COCHIN SPECIAL ECONOMIC ZONE Kakkanad, Cochin, 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 | 2002-04-02 |
| Decision Date | 2002-05-08 |