KIMBERLY-CLARK STERLING NITRILE & NITRILE-XTRA POWDER-FREE EXAM GLOVES WITH CHEMOTHERAPY DRUG USE CLAIM

Patient Examination Glove, Specialty

KIMBERLY-CLARK CORP.

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.

Pre-market Notification Details

Device IDK081089
510k NumberK081089
Device Name:KIMBERLY-CLARK STERLING NITRILE & NITRILE-XTRA POWDER-FREE EXAM GLOVES WITH CHEMOTHERAPY DRUG USE CLAIM
ClassificationPatient Examination Glove, Specialty
Applicant KIMBERLY-CLARK CORP. 1400 HOLCOMB BRIDGE RD. Roswell,  GA  30076
ContactRichard V Wolfe
CorrespondentRichard V Wolfe
KIMBERLY-CLARK CORP. 1400 HOLCOMB BRIDGE RD. Roswell,  GA  30076
Product CodeLZC  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-04-16
Decision Date2008-07-14
Summary:summary

NIH GUDID Devices

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