The following data is part of a premarket notification filed by Primus Gloves Private Ltd. with the FDA for Vinyl Examination Gloves Sterile Powedered.
| Device ID | K020044 |
| 510k Number | K020044 |
| Device Name: | VINYL EXAMINATION GLOVES STERILE POWEDERED |
| Classification | Vinyl Patient Examination Glove |
| 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 | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-01-07 |
| Decision Date | 2002-02-26 |