The following data is part of a premarket notification filed by Safeskin Corp. with the FDA for Safeskin Supra.
| Device ID | K953015 |
| 510k Number | K953015 |
| Device Name: | SAFESKIN SUPRA |
| Classification | Surgeon's Gloves |
| Applicant | SAFESKIN CORP. 6815 FLANDERS DR. San Diego, CA 92121 |
| Contact | Wava Truscott |
| Correspondent | Wava Truscott SAFESKIN CORP. 6815 FLANDERS DR. San Diego, CA 92121 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-29 |
| Decision Date | 1995-08-28 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SAFESKIN SUPRA 74549262 1953750 Dead/Cancelled |
SAFESKIN CORPORATION 1994-07-14 |