Sterile Latex Surgical Glove, Powder Free

Surgeon's Gloves

Careglove Global Sdn Bhd

The following data is part of a premarket notification filed by Careglove Global Sdn Bhd with the FDA for Sterile Latex Surgical Glove, Powder Free.

Pre-market Notification Details

Device IDK190241
510k NumberK190241
Device Name:Sterile Latex Surgical Glove, Powder Free
ClassificationSurgeon's Gloves
Applicant Careglove Global Sdn Bhd Lot 17479, Lrg Senawang 3/2, Off Jln Senawang 3, Senawang In Seremban,  MY 70450
ContactLim Kwee Shyan
CorrespondentLim Kwee Shyan
Careglove Global Sdn Bhd Lot 17479, Lrg Senawang 3/2, Off Jln Senawang 3, Senawang In Seremban,  MY 70450
Product CodeKGO  
CFR Regulation Number878.4460 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-02-06
Decision Date2019-12-30
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
09551006061058 K190241 000
00304040190111 K190241 000
00304040190128 K190241 000
00304040190135 K190241 000
00304040190142 K190241 000
00304040190159 K190241 000
00304040190166 K190241 000
00304040190173 K190241 000
09551006060471 K190241 000
09551006060488 K190241 000
09551006060495 K190241 000
09551006060501 K190241 000
09551006060518 K190241 000
09551006061034 K190241 000
09551006061041 K190241 000
00304040190104 K190241 000

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