The following data is part of a premarket notification filed by Maxxim Medical with the FDA for Sterile Sensicare Synthetic Polyisoprene Powder-free Surgical Gloves.
| Device ID | K002933 |
| 510k Number | K002933 |
| Device Name: | STERILE SENSICARE SYNTHETIC POLYISOPRENE POWDER-FREE SURGICAL GLOVES |
| Classification | Surgeon's Gloves |
| Applicant | MAXXIM MEDICAL 308 CHURCH ST Honea Path, SC 29654 |
| Contact | Pallie Stoddard |
| Correspondent | Pallie Stoddard MAXXIM MEDICAL 308 CHURCH ST Honea 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 | 2000-09-20 |
| Decision Date | 2000-10-19 |