KIMBERLY-CLARK STERLING NITRILE POWDER-FREE EXAM GLOVE (STERILE)

Polymer Patient Examination Glove

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 Powder-free Exam Glove (sterile).

Pre-market Notification Details

Device IDK081027
510k NumberK081027
Device Name:KIMBERLY-CLARK STERLING NITRILE POWDER-FREE EXAM GLOVE (STERILE)
ClassificationPolymer Patient Examination Glove
Applicant KIMBERLY-CLARK CORP. 1400 HOLCOMB BRIDGE RD. Roswell,  GA  30076
ContactRichard W Wolfe
CorrespondentRichard W Wolfe
KIMBERLY-CLARK CORP. 1400 HOLCOMB BRIDGE RD. Roswell,  GA  30076
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-04-10
Decision Date2008-06-30
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20036000531323 K081027 000
30680651449888 K081027 000
30680651449895 K081027 000
30680651449901 K081027 000
30680651449918 K081027 000
30680651531309 K081027 000
30680651531316 K081027 000
30680651531323 K081027 000
20036000531309 K081027 000
20036000531316 K081027 000
30680651449871 K081027 000

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