Non-Sterile Powder Free Blue Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs

Patient Examination Glove, Specialty

Maxter Glove Manufacturing Sdn Bhd

The following data is part of a premarket notification filed by Maxter Glove Manufacturing Sdn Bhd with the FDA for Non-sterile Powder Free Blue Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs.

Pre-market Notification Details

Device IDK172864
510k NumberK172864
Device Name:Non-Sterile Powder Free Blue Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs
ClassificationPatient Examination Glove, Specialty
Applicant Maxter Glove Manufacturing Sdn Bhd Lot 6070, Jalan Haji Abdul Manah 6th Miles Off Jalan Meru Klang,  MY 41050
ContactYap Peak Geeh
CorrespondentYap Peak Geeh
Maxter Glove Manufacturing Sdn Bhd Lot 6070, Jalan Haji Abdul Manah 6th Miles Off Jalan Meru Klang,  MY 41050
Product CodeLZC  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-09-20
Decision Date2018-05-02
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.