The following data is part of a premarket notification filed by Kimberly-clark Corp. with the FDA for Safeskin Neon Nitrile - Powder Free Neon Exam Glove.
| Device ID | K011713 |
| 510k Number | K011713 |
| Device Name: | SAFESKIN NEON NITRILE - POWDER FREE NEON EXAM GLOVE |
| Classification | Polymer 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 | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-04 |
| Decision Date | 2001-07-05 |
| Summary: | summary |