MODIFICATION TO POWDERFREE COLORED AND FLAVORED CHLOROPRENE PATIENT EXAMINATION GLOVES

Polymer Patient Examination Glove

PT. MEDISAFE TECHNOLOGIES

The following data is part of a premarket notification filed by Pt. Medisafe Technologies with the FDA for Modification To Powderfree Colored And Flavored Chloroprene Patient Examination Gloves.

Pre-market Notification Details

Device IDK040607
510k NumberK040607
Device Name:MODIFICATION TO POWDERFREE COLORED AND FLAVORED CHLOROPRENE PATIENT EXAMINATION GLOVES
ClassificationPolymer Patient Examination Glove
Applicant PT. MEDISAFE TECHNOLOGIES JL. KAPT. PATTIMURA NO. 23 Medan, North Sumatra,  ID 20153
ContactAnil Taneja
CorrespondentAnil Taneja
PT. MEDISAFE TECHNOLOGIES JL. KAPT. PATTIMURA NO. 23 Medan, North Sumatra,  ID 20153
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-03-08
Decision Date2004-04-22

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00686864059561 K040607 000
20686864056083 K040607 000
20686864056076 K040607 000
20686864056069 K040607 000
20686864056052 K040607 000
20686864056045 K040607 000

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