Nitrile Examination Gloves Powder Free (Tested For Use With Chemotherapy Drugs)

Polymer Patient Examination Glove

PT. Sintong Unigolden Glove

The following data is part of a premarket notification filed by Pt. Sintong Unigolden Glove with the FDA for Nitrile Examination Gloves Powder Free (tested For Use With Chemotherapy Drugs).

Pre-market Notification Details

Device IDK223235
510k NumberK223235
Device Name:Nitrile Examination Gloves Powder Free (Tested For Use With Chemotherapy Drugs)
ClassificationPolymer Patient Examination Glove
Applicant PT. Sintong Unigolden Glove Jl. Lintas Sumatera, Kel. Hessa Perlompongan, Kec. Air Batu, Kab. Asahan Kota Kisaran,  ID 21272
ContactMP Vivekanandan
CorrespondentManoj Zacharias
Liberty Management Group Ltd. 75 Executive Dr. STE 114 Aurora,  IL  60504
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-10-13
Decision Date2022-10-26

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