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

Polymer Patient Examination Glove

CRDLight Optoelectronic Technology Co., Ltd

The following data is part of a premarket notification filed by Crdlight Optoelectronic Technology Co., Ltd with the FDA for Disposable Powder Free Nitrile Exam Gloves (tested For Use With Chemotherapy Drugs).

Pre-market Notification Details

Device IDK212532
510k NumberK212532
Device Name:Disposable Powder Free Nitrile Exam Gloves (Tested For Use With Chemotherapy Drugs)
ClassificationPolymer Patient Examination Glove
Applicant CRDLight Optoelectronic Technology Co., Ltd Floor 1-5 Building No.7 & Floor 1-4 Building No.5 No.18 Xinyi Road, Jianghai Jiangmen,  CN
ContactFishy Liang
CorrespondentIvy Wang
Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Central Avenue Shanghai,  CN 200122
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-11
Decision Date2021-11-11

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