Polychloroprene Powder Free Sterile Surgical Gloves, Low Dermatitis Potential And Tested For Use With Chemotherapy Drugs

Surgeon's Gloves

PT. Medisafe Technologies

The following data is part of a premarket notification filed by Pt. Medisafe Technologies with the FDA for Polychloroprene Powder Free Sterile Surgical Gloves, Low Dermatitis Potential And Tested For Use With Chemotherapy Drugs.

Pre-market Notification Details

Device IDK201774
510k NumberK201774
Device Name:Polychloroprene Powder Free Sterile Surgical Gloves, Low Dermatitis Potential And Tested For Use With Chemotherapy Drugs
ClassificationSurgeon's Gloves
Applicant PT. Medisafe Technologies J1 Batang Kuis, Gg Tambak Rejo Pasar IX, Desa Buntu Bedimbar Tanjung Morawa, Medan,  ID 20362
ContactSajeev Joseph
CorrespondentPunitha Samy
PT. Medisafe Technologies J1 Batang Kuis, Gg Tambak Rejo Pasar IX, Desa Buntu Bedimbar Tanjung Morawa, Medan,  ID 20362
Product CodeKGO  
CFR Regulation Number878.4460 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-29
Decision Date2020-09-16

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