Latex Surgical Gloves, Powder Free With Protein Claim (50 Micrograms Or Less)

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 Latex Surgical Gloves, Powder Free With Protein Claim (50 Micrograms Or Less).

Pre-market Notification Details

Device IDK211621
510k NumberK211621
Device Name:Latex Surgical Gloves, Powder Free With Protein Claim (50 Micrograms Or Less)
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 Received2021-05-26
Decision Date2021-10-06

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