The following data is part of a premarket notification filed by Maxxim Medical, Inc. with the FDA for Senicare Advantix Powder Free Polyurethane Medical Examination Glove, Sensicare Advantix Powder Free Polyurethane Dental.
| Device ID | K011198 |
| 510k Number | K011198 |
| Device Name: | SENICARE ADVANTIX POWDER FREE POLYURETHANE MEDICAL EXAMINATION GLOVE, SENSICARE ADVANTIX POWDER FREE POLYURETHANE DENTAL |
| Classification | Polymer Patient Examination Glove |
| Applicant | MAXXIM MEDICAL, INC. 10300 49TH ST. NORTH Clearwater, FL 33762 |
| Contact | Jamal S Alnaser |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2001-04-19 |
| Decision Date | 2001-05-17 |