The following data is part of a premarket notification filed by Safeskin Corp. with the FDA for Safeskin Pfe-xtra Powder-free Latex Examination Gloves, Protein Content 50 Mcg Or Less, For Use With Chemotherapeutic Ag.
| Device ID | K993117 |
| 510k Number | K993117 |
| Device Name: | SAFESKIN PFE-XTRA POWDER-FREE LATEX EXAMINATION GLOVES, PROTEIN CONTENT 50 MCG OR LESS, FOR USE WITH CHEMOTHERAPEUTIC AG |
| Classification | Latex Patient Examination Glove |
| 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 | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-20 |
| Decision Date | 2000-03-02 |
| Summary: | summary |