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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 K213440
Device Name Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested for Use with Chemotherapy Drugs
Luliang Hongruida Health Protection Technology Co., Ltd.
Zhaokua Area, Luliang Industrial Zone
Qujing,  CN 655606
Applicant Contact Zhang Guocai
Hongray USA Medical Products Inc.
3973 Schaefer Avenue,
Chino,  CA  91710
Correspondent Contact Kathy Liu
Regulation Number880.6250
Classification Product Code
Subsequent Product Code
Date Received10/25/2021
Decision Date 02/18/2022
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