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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)
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
Applicant Contact Fishy Liang
Correspondent
Shanghai Sungo Management Consulting Company Limited
14th Floor, 1500# Central Avenue
Shanghai,  CN 200122
Correspondent Contact Ivy Wang
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Code
LZC  
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
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