The following data is part of a premarket notification filed by Kimberly-clark Corp. with the FDA for Kimberly-clark Lavender Nitrile Powder-free Exam Glove.
| Device ID | K131841 |
| 510k Number | K131841 |
| Device Name: | KIMBERLY-CLARK LAVENDER NITRILE POWDER-FREE EXAM GLOVE |
| Classification | Polymer Patient Examination Glove |
| Applicant | KIMBERLY-CLARK CORP. 1400 HOLCOMB BRIDGE RD. Roswell, GA 30076 |
| Contact | Christine L Macauley |
| Correspondent | Christine L Macauley 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 | 2013-06-21 |
| Decision Date | 2013-11-07 |
| Summary: | summary |