The following data is part of a premarket notification filed by Barriermed Glove Co. with the FDA for Barrierplus Gold Ortho Powder-free Synthetic Polyisoprene Orthopedic Surgical Gloves.
| Device ID | K052772 |
| 510k Number | K052772 |
| Device Name: | BARRIERPLUS GOLD ORTHO POWDER-FREE SYNTHETIC POLYISOPRENE ORTHOPEDIC SURGICAL GLOVES |
| 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 | 2005-10-03 |
| Decision Date | 2005-12-20 |