The following data is part of a premarket notification filed by Maxxim Medical, Inc. with the FDA for Eudermic Pf Powder-free Surgical Gloves.
| Device ID | K001343 |
| 510k Number | K001343 |
| Device Name: | EUDERMIC PF POWDER-FREE SURGICAL GLOVES |
| Classification | Surgeon's Gloves |
| Applicant | MAXXIM MEDICAL, INC. 308 CHURCH ST. Hone Path, SC 29654 |
| Contact | Pallie Stoddard |
| Correspondent | Pallie Stoddard MAXXIM MEDICAL, INC. 308 CHURCH ST. Hone Path, SC 29654 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-27 |
| Decision Date | 2000-06-12 |