The following data is part of a premarket notification filed by Kimberly-clark Corp. with the FDA for Kimberly-clark *lavender* Nitrile Power-free Exam Gloves.
| Device ID | K081260 |
| 510k Number | K081260 |
| Device Name: | KIMBERLY-CLARK *LAVENDER* NITRILE POWER-FREE EXAM GLOVES |
| Classification | Polymer Patient Examination Glove |
| Applicant | KIMBERLY-CLARK CORP. 1400 HOLCOMB BRIDGE RD. Roswell, GA 30076 |
| Contact | Richard V Wolfe |
| Correspondent | Richard V Wolfe 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 | 2008-05-02 |
| Decision Date | 2008-07-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30680651470318 | K081260 | 000 |
| 30680651452789 | K081260 | 000 |
| 30680651452772 | K081260 | 000 |
| 30680651452765 | K081260 | 000 |
| 30680651452758 | K081260 | 000 |
| 30680651483653 | K081260 | 000 |
| 20680651483649 | K081260 | 000 |
| 30680651483639 | K081260 | 000 |
| 30680651477447 | K081260 | 000 |
| 30680651452796 | K081260 | 000 |
| 30680651470158 | K081260 | 000 |
| 30680651470301 | K081260 | 000 |
| 30680651470295 | K081260 | 000 |
| 30680651470288 | K081260 | 000 |
| 30680651470271 | K081260 | 000 |
| 30680651470196 | K081260 | 000 |
| 30680651470189 | K081260 | 000 |
| 30680651470172 | K081260 | 000 |
| 30680651470165 | K081260 | 000 |
| 30680651477409 | K081260 | 000 |