The following data is part of a premarket notification filed by Maxxim Medical with the FDA for Dextren Clear Powder-free Hypoallergenic Surgical Gloves.
| Device ID | K962813 |
| 510k Number | K962813 |
| Device Name: | DEXTREN CLEAR POWDER-FREE HYPOALLERGENIC SURGICAL GLOVES |
| Classification | Surgeon's Gloves |
| Applicant | MAXXIM MEDICAL 4750 118TH AVENUE NORTH Clearwater, FL 33762 |
| Contact | Joyce Moody |
| Correspondent | Joyce Moody MAXXIM MEDICAL 4750 118TH AVENUE NORTH Clearwater, FL 33762 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-19 |
| Decision Date | 1997-01-30 |