The following data is part of a premarket notification filed by Kimberly-clark Corp. with the FDA for Kimberly-clark Sterling Nitrile & Nitrile-xtra Powder-free Exam Gloves With Chemotherapy Drug Use Claim.
| Device ID | K081089 |
| 510k Number | K081089 |
| Device Name: | KIMBERLY-CLARK STERLING NITRILE & NITRILE-XTRA POWDER-FREE EXAM GLOVES WITH CHEMOTHERAPY DRUG USE CLAIM |
| Classification | Patient Examination Glove, Specialty |
| 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 | LZC |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-16 |
| Decision Date | 2008-07-14 |
| Summary: | summary |