Nitrile Powder Free Examination Glove With Colloidal Oatmeal USP Tested For Use With Chemotherapy Drugs

Polymer Patient Examination Glove

HARTALEGA SND. BHD.

The following data is part of a premarket notification filed by Hartalega Snd. Bhd. with the FDA for Nitrile Powder Free Examination Glove With Colloidal Oatmeal Usp Tested For Use With Chemotherapy Drugs.

Pre-market Notification Details

Device IDK160562
510k NumberK160562
Device Name:Nitrile Powder Free Examination Glove With Colloidal Oatmeal USP Tested For Use With Chemotherapy Drugs
ClassificationPolymer Patient Examination Glove
Applicant HARTALEGA SND. BHD. C-G-1, JALAN DATARAN SD1 DATARAN SD PJU 9 Bandar Sri Damansara,  MY 52200
ContactKuan Kam Hon
CorrespondentH. Carl Jenkins
HARTALEGA SND. BHD. 10 E. Scranton Ave. Suite 201 Lake Bluff,  IL  60044
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-02-29
Decision Date2016-10-13

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