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

Polymer Patient Examination Glove

Anhui Zhong Lian Latex Gloves Manufacturing Co., Ltd.

The following data is part of a premarket notification filed by Anhui Zhong Lian Latex Gloves Manufacturing Co., Ltd. with the FDA for Disposable Nitrile Powder-free Examination Gloves (tested For Use With Chemotherapy Drugs).

Pre-market Notification Details

Device IDK220488
510k NumberK220488
Device Name:Disposable Nitrile Powder-Free Examination Gloves (Tested For Use With Chemotherapy Drugs)
ClassificationPolymer Patient Examination Glove
Applicant Anhui Zhong Lian Latex Gloves Manufacturing Co., Ltd. Guzhen Economic Development Zone Bengbu,  CN 233799
ContactKitty Xu
CorrespondentBoyle Wang
Shanghai Truthful Information Technology Co., Ltd. Room608,No.738,Shangcheng Rd.,Pudong Shanghai,  CN 200120
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-02-22
Decision Date2022-06-01

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