The following data is part of a premarket notification filed by Barriermed Glove Co. with the FDA for Barrierplus Platinum Powder-free Synthetic Polychloroprene Surgical Gloves, Models 12544-125490.
| Device ID | K061038 |
| 510k Number | K061038 |
| Device Name: | BARRIERPLUS PLATINUM POWDER-FREE SYNTHETIC POLYCHLOROPRENE SURGICAL GLOVES, MODELS 12544-125490 |
| Classification | Surgeon's Gloves |
| Applicant | BARRIERMED GLOVE CO. 155 TECHNOLOGY PARK Lake Mary, FL 32746 |
| Contact | Victor J Ragucci |
| Correspondent | Victor J Ragucci BARRIERMED GLOVE CO. 155 TECHNOLOGY PARK Lake Mary, FL 32746 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-14 |
| Decision Date | 2006-06-23 |