The following data is part of a premarket notification filed by Preventive Care, Inc. with the FDA for Powderfree Latex Examination Gloves Coated With Allogel.
| Device ID | K130667 |
| 510k Number | K130667 |
| Device Name: | POWDERFREE LATEX EXAMINATION GLOVES COATED WITH ALLOGEL |
| Classification | Latex 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 | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-12 |
| Decision Date | 2013-07-24 |
| Summary: | summary |