The following data is part of a premarket notification filed by Safeskin Corp. with the FDA for Safeskin Synthetic Binyo Powder-free Polymer Coated Examination Gloves (green, White).
| Device ID | K991951 |
| 510k Number | K991951 |
| Device Name: | SAFESKIN SYNTHETIC BINYO POWDER-FREE POLYMER COATED EXAMINATION GLOVES (GREEN, WHITE) |
| Classification | Vinyl 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 | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-10 |
| Decision Date | 1999-07-26 |
| Summary: | summary |