Polyisoprene Powder Free Surgical Underglove For Use With Chemotherapy Drugs (Blue), Polyisoprene Powder Free Surgical Glove For Use With Chemotherapy Drugs (Natural)

Surgeon's Gloves

Hartalega SDN. BHD.

The following data is part of a premarket notification filed by Hartalega Sdn. Bhd. with the FDA for Polyisoprene Powder Free Surgical Underglove For Use With Chemotherapy Drugs (blue), Polyisoprene Powder Free Surgical Glove For Use With Chemotherapy Drugs (natural).

Pre-market Notification Details

Device IDK200897
510k NumberK200897
Device Name:Polyisoprene Powder Free Surgical Underglove For Use With Chemotherapy Drugs (Blue), Polyisoprene Powder Free Surgical Glove For Use With Chemotherapy Drugs (Natural)
ClassificationSurgeon's Gloves
Applicant Hartalega SDN. BHD. Dataran SD PJU9 Bandar Sri Damansara,  MY 52200
ContactKuan Kam Hon
CorrespondentNurul Aisyah Kong
Hartalega SDN. NHD NO. 7, Kawasan Perusahaan Suria Bestari Jaya,  MY 45600
Product CodeKGO  
CFR Regulation Number878.4460 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-03
Decision Date2020-06-01

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