The following data is part of a premarket notification filed by Barriermed Glove Co. with the FDA for Barrierplus Synthetic Powder-free Surgical Gloves.
| Device ID | K990710 |
| 510k Number | K990710 |
| Device Name: | BARRIERPLUS SYNTHETIC POWDER-FREE SURGICAL GLOVES |
| Classification | Surgeon's Gloves |
| Applicant | BARRIERMED GLOVE CO. 2500 WEST LAKE MARY BLVD. Lake Mary, FL 32746 |
| Contact | Carlo Poncipe |
| Correspondent | Carlo Poncipe BARRIERMED GLOVE CO. 2500 WEST LAKE MARY BLVD. 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 | 1999-03-04 |
| Decision Date | 1999-05-20 |