The following data is part of a premarket notification filed by Safeskin Corp. with the FDA for Safeskin Powdered Examination Glove.
| Device ID | K970899 |
| 510k Number | K970899 |
| Device Name: | SAFESKIN POWDERED EXAMINATION GLOVE |
| Classification | Latex Patient Examination Glove |
| Applicant | SAFESKIN CORP. 12671 HIGH BLUFF DR. San Diego, CA 92130 |
| Contact | Michelle Molloy |
| Correspondent | Michelle Molloy 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 | 1997-03-11 |
| Decision Date | 1997-05-06 |