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 |