KIMBERLY-CLARK PURPLE NITRILE POWDER-FREE EXAM GLOVE (CHEMOTHERAPY GLOVE) AND KIMBERLY-CLARK PURPLE NITRILE XTRA POWDER-

Patient Examination Glove, Specialty

KIMBERLY-CLARK

The following data is part of a premarket notification filed by Kimberly-clark with the FDA for Kimberly-clark Purple Nitrile Powder-free Exam Glove (chemotherapy Glove) And Kimberly-clark Purple Nitrile Xtra Powder-.

Pre-market Notification Details

Device IDK101596
510k NumberK101596
Device Name:KIMBERLY-CLARK PURPLE NITRILE POWDER-FREE EXAM GLOVE (CHEMOTHERAPY GLOVE) AND KIMBERLY-CLARK PURPLE NITRILE XTRA POWDER-
ClassificationPatient Examination Glove, Specialty
Applicant KIMBERLY-CLARK 1400 HOLCOMB BRIDGE ROAD Roswell,  GA  30097
ContactLester F Padilla
CorrespondentNed Devine
UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook,  IL  60062
Product CodeLZC  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2010-06-08
Decision Date2010-07-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10036012550803 K101596 000
10036000550815 K101596 000
10036000550822 K101596 000
10036000550839 K101596 000
10036000550846 K101596 000
10036008550831 K101596 000
10036009550823 K101596 000
10036010550812 K101596 000
10036011550842 K101596 000
10036000550808 K101596 000

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