The following data is part of a premarket notification filed by Safeskin Corp. with the FDA for Safeskin Polymer-coated Nitrile Examination Gloves, Powder-free Shieldmaster Nitrile Glove.
| Device ID | K992830 |
| 510k Number | K992830 |
| Device Name: | SAFESKIN POLYMER-COATED NITRILE EXAMINATION GLOVES, POWDER-FREE SHIELDMASTER NITRILE GLOVE |
| Classification | Polymer 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 | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-23 |
| Decision Date | 1999-10-27 |
| Summary: | summary |