ENCORE Latex Textured Surgical Gloves, Powder Free With Protein Content Labeling Claim (50 Micrograms Or Less) And Tested For Use With Chemotherapy Drugs

Surgeon's Gloves

Careplus (M) SDN BHD

The following data is part of a premarket notification filed by Careplus (m) Sdn Bhd with the FDA for Encore Latex Textured Surgical Gloves, Powder Free With Protein Content Labeling Claim (50 Micrograms Or Less) And Tested For Use With Chemotherapy Drugs.

Pre-market Notification Details

Device IDK202765
510k NumberK202765
Device Name:ENCORE Latex Textured Surgical Gloves, Powder Free With Protein Content Labeling Claim (50 Micrograms Or Less) And Tested For Use With Chemotherapy Drugs
ClassificationSurgeon's Gloves
Applicant Careplus (M) SDN BHD Lot 120 & 121, Jalan Senawang 3, Senawang Industrial Estate Seremban,  MY 70450
ContactLim Kwee Shyan
CorrespondentLim Kwee Shyan
Careplus (M) SDN BHD Lot 120 & 121, Jalan Senawang 3, Senawang Industrial Estate Seremban,  MY 70450
Product CodeKGO  
CFR Regulation Number878.4460 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-21
Decision Date2021-05-27

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