Best Glove-Latex Powder Free Examination Glove

Latex Patient Examination Glove

Bestsafe Glove CO., LTD.

The following data is part of a premarket notification filed by Bestsafe Glove Co., Ltd. with the FDA for Best Glove-latex Powder Free Examination Glove.

Pre-market Notification Details

Device IDK210253
510k NumberK210253
Device Name:Best Glove-Latex Powder Free Examination Glove
ClassificationLatex Patient Examination Glove
Applicant Bestsafe Glove CO., LTD. 52/43 Wat Khot Hin-Khao Phai Road, T. Tubma Muang Rayong,  TH 21000
ContactPiyawat Chirasakulkarun
CorrespondentPiyawat Chirasakulkarun
Bestsafe Glove CO., LTD. 52/43 Wat Khot Hin-Khao Phai Road, T. Tubma Muang Rayong,  TH 21000
Product CodeLYY  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-01-29
Decision Date2021-11-05

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