The following data is part of a premarket notification filed by Safeskin Corp. with the FDA for Safeskin Tactylon Pf Powder-free Surgeon's Gloves.
| Device ID | K994081 |
| 510k Number | K994081 |
| Device Name: | SAFESKIN TACTYLON PF POWDER-FREE SURGEON'S GLOVES |
| Classification | Surgeon's Gloves |
| Applicant | SAFESKIN CORP. 12671 HIGH BLUFF DR. San Diego, CA 92130 |
| Contact | Eugene V Goorchenko |
| Correspondent | Eugene V Goorchenko SAFESKIN CORP. 12671 HIGH BLUFF DR. San Diego, CA 92130 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-03 |
| Decision Date | 2000-01-18 |
| Summary: | summary |