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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name surgeon's gloves
510(k) Number K230217
Device Name Sterile Polyisoprene Powder Free Surgical Glove, Tested for Use with Chemotherapy Drugs
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 Number878.4460
Classification Product Code
KGO  
Subsequent Product Code
LZC  
Date Received01/26/2023
Decision Date 05/13/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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