Powder Free Examination Gloves With Colloidal Oatmeal USP And Tested For Use With Chemotherapy Drugs - (Lemon Green)

Polymer Patient Examination Glove

Hartalega Sdn Bhd

The following data is part of a premarket notification filed by Hartalega Sdn Bhd with the FDA for Powder Free Examination Gloves With Colloidal Oatmeal Usp And Tested For Use With Chemotherapy Drugs - (lemon Green).

Pre-market Notification Details

Device IDK180645
510k NumberK180645
Device Name:Powder Free Examination Gloves With Colloidal Oatmeal USP And Tested For Use With Chemotherapy Drugs - (Lemon Green)
ClassificationPolymer Patient Examination Glove
Applicant Hartalega Sdn Bhd C-G-9, Jalan Dataran Sd 1 Dataran Sd Pju 9 Bandar Sri Damansara,  MY 52200
ContactMr. Kuan Kam Hon
CorrespondentNural Aisyah Kong
Hartalega Sdn. Bhd. NO.7, Kawasan Perusahaan Suria Bestari Jaya,  MY 52200
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2018-03-12
Decision Date2018-11-16

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