The following data is part of a premarket notification filed by Maxxim Medical with the FDA for Sensicare -c Synthetic Polyisoprene Powder-free Surgical Gloves.
| Device ID | K023236 |
| 510k Number | K023236 |
| Device Name: | SENSICARE -C SYNTHETIC POLYISOPRENE POWDER-FREE SURGICAL GLOVES |
| Classification | Surgeon's Gloves |
| Applicant | MAXXIM MEDICAL 308 CHURCH ST Honea Path, SC 29654 |
| Contact | Roy E Moser |
| Correspondent | Roy E Moser MAXXIM MEDICAL 308 CHURCH ST Honea Path, SC 29654 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-27 |
| Decision Date | 2002-11-12 |
| Summary: | summary |