The following data is part of a premarket notification filed by Surgikos, Inc. with the FDA for Neutralon Surgical Gloves.
| Device ID | K861441 |
| 510k Number | K861441 |
| Device Name: | NEUTRALON SURGICAL GLOVES |
| Classification | Surgeon's Gloves |
| Applicant | SURGIKOS, INC. P.O. BOX 130 Arlington, TX 76010 |
| Contact | Christal O Fisher |
| Correspondent | Christal O Fisher SURGIKOS, INC. P.O. BOX 130 Arlington, TX 76010 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-17 |
| Decision Date | 1986-05-30 |