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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 K213574
Device Name Nitrile Vinyl Blend Powder Free Examination Gloves (Black)
Applicant
Grand Work Plastic Products Co., Ltd
Donggao Industrial Zone, Zanhuang
Shijiazhuang,  CN 050000
Applicant Contact Wu Yuli
Correspondent
Hongray USA Medical Products Inc.
3973 Schaefer Avenue
Chino,  CA  91710
Correspondent Contact Kathy Liu
Regulation Number880.6250
Classification Product Code
LZA  
Date Received11/10/2021
Decision Date 07/12/2022
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
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