The following data is part of a premarket notification filed by Kimberly-clark Corp. with the FDA for Safeskin Healthtouch Powder-free Exam Glove With Vitamin E And Aloe.
| Device ID | K012815 |
| 510k Number | K012815 |
| Device Name: | SAFESKIN HEALTHTOUCH POWDER-FREE EXAM GLOVE WITH VITAMIN E AND ALOE |
| Classification | Latex Patient Examination Glove |
| Applicant | KIMBERLY-CLARK CORP. 1400 HOLCOMB BRIDGE RD. Roswell, GA 30076 |
| Contact | Marcia Johnson |
| Correspondent | Marcia Johnson KIMBERLY-CLARK CORP. 1400 HOLCOMB BRIDGE RD. Roswell, GA 30076 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-22 |
| Decision Date | 2001-11-13 |
| Summary: | summary |