Nitrile Powder Free Examination Glove Tested For Use With Chemotherapy Drugs (Pink)

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 Nitrile Powder Free Examination Glove Tested For Use With Chemotherapy Drugs (pink).

Pre-market Notification Details

Device IDK173137
510k NumberK173137
Device Name:Nitrile Powder Free Examination Glove Tested For Use With Chemotherapy Drugs (Pink)
ClassificationPolymer Patient Examination Glove
Applicant Hartalega Sdn. Bhd. Dataran Sd Pju 9 Bandar Sri Damansara,  MY 52200
ContactKuan Kam Hon
CorrespondentNurul Aisyah Kong
Hartalega Sdn. Bhd No.7, Kawasan Perusahaan Suria Bestari Jaya,  MY 45600
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-09-29
Decision Date2017-12-12

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00686864059479 K173137 000
20686864046138 K173137 000
20686864040822 K173137 000
20686864040815 K173137 000
20686864040808 K173137 000

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