The following data is part of a premarket notification filed by Preventive Care, Inc. with the FDA for Powderfree Nitrile Examination Gloves Coated With Allogel,colors Blue,magneta,copper And Without Allogel,colors Blue,mag.
| Device ID | K110102 |
| 510k Number | K110102 |
| Device Name: | POWDERFREE NITRILE EXAMINATION GLOVES COATED WITH ALLOGEL,COLORS BLUE,MAGNETA,COPPER AND WITHOUT ALLOGEL,COLORS BLUE,MAG |
| Classification | Polymer Patient Examination Glove |
| Applicant | PREVENTIVE CARE, INC. 15215 BOULDER TRAIL Rosemount, MN 55068 |
| Contact | Anil Segat |
| Correspondent | Anil Segat PREVENTIVE CARE, INC. 15215 BOULDER TRAIL Rosemount, MN 55068 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-01-13 |
| Decision Date | 2011-05-13 |
| Summary: | summary |