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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name polymer patient examination glove
510(k) Number K212532
Device Name Disposable Powder Free Nitrile Exam Gloves (Tested For Use With Chemotherapy Drugs)
CRDLight Optoelectronic Technology Co., Ltd
Floor 1-5 Building No.7 & Floor 1-4 Building No.5 No.18
Xinyi Road, Jianghai
Jiangmen,  CN
Applicant Contact Fishy Liang
Shanghai Sungo Management Consulting Company Limited
14th Floor, 1500# Central Avenue
Shanghai,  CN 200122
Correspondent Contact Ivy Wang
Regulation Number880.6250
Classification Product Code
Subsequent Product Code
Date Received08/11/2021
Decision Date 11/11/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No