LYDUS Nitrite Examination Gloves, Powder Free

Polymer Patient Examination Glove

Nathan Trading Co., Ltd

The following data is part of a premarket notification filed by Nathan Trading Co., Ltd with the FDA for Lydus Nitrite Examination Gloves, Powder Free.

Pre-market Notification Details

Device IDK203191
510k NumberK203191
Device Name:LYDUS Nitrite Examination Gloves, Powder Free
ClassificationPolymer Patient Examination Glove
Applicant Nathan Trading Co., Ltd 58 Moo 12 Palan Sub-District Nathan District,  TH 34170
ContactChansamone Saiyasak
CorrespondentAbdel B. Halim
Global Quality And Regulatory Services 10 Scenic Way Monroe,  NJ  08831
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedYes
Combination ProductNo
Date Received2020-10-27
Decision Date2021-02-12

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