Synthetic Nitrile Patient Exam Gloves, Powder Free, Blue, Tested For Use W/Chemotherapy Drug

Polymer Patient Examination Glove

Anhui Lntco Medical Products Co., Ltd.

The following data is part of a premarket notification filed by Anhui Lntco Medical Products Co., Ltd. with the FDA for Synthetic Nitrile Patient Exam Gloves, Powder Free, Blue, Tested For Use W/chemotherapy Drug.

Pre-market Notification Details

Device IDK200093
510k NumberK200093
Device Name:Synthetic Nitrile Patient Exam Gloves, Powder Free, Blue, Tested For Use W/Chemotherapy Drug
ClassificationPolymer Patient Examination Glove
Applicant Anhui Lntco Medical Products Co., Ltd. No. 1 Haitang Road, Suixi District Economic Development Area Huaibei City,  CN 235100
ContactJacken Cai
CorrespondentJason Ji
lntco Medical Industries, Inc. 805 Barrington Ave Ontario,  CA  91764
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-01-16
Decision Date2020-08-20

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