Powder Free NR Latex Surgical Glove (Sterile) With Protein Content Labelling Claims 50ug/dm2 Or Less Per Glove Of Extractable Protein

Surgeon's Gloves

ECO Medi Glove Sdn. Bhd

The following data is part of a premarket notification filed by Eco Medi Glove Sdn. Bhd with the FDA for Powder Free Nr Latex Surgical Glove (sterile) With Protein Content Labelling Claims 50ug/dm2 Or Less Per Glove Of Extractable Protein.

Pre-market Notification Details

Device IDK202401
510k NumberK202401
Device Name:Powder Free NR Latex Surgical Glove (Sterile) With Protein Content Labelling Claims 50ug/dm2 Or Less Per Glove Of Extractable Protein
ClassificationSurgeon's Gloves
Applicant ECO Medi Glove Sdn. Bhd Lot 26910, Lorong Perusahaan 3/3, Kawasan Perusahaan, Kamunting Raya Taiping,  MY 34600
ContactSuresh Kumar
CorrespondentSuresh Kumar
ECO Medi Glove Sdn. Bhd Lot 26910, Lorong Perusahaan 3/3, Kawasan Perusahaan, Kamunting Raya Taiping,  MY 34600
Product CodeKGO  
CFR Regulation Number878.4460 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-21
Decision Date2021-02-17

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