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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 K233182
Device Name Powder Free Nitrile Examination Gloves (Blue, White, Black and/or Violet Blue)
Applicant
Zibo Kaiyue Mould Technology Co., Ltd.
# 268 Taishan Rd., Guoli Town, Huantai County
Zibo,  CN 256400
Applicant Contact Cindy Lee
Correspondent
Zibo Kaiyue Mould Technology Co., Ltd.
# 268 Taishan Rd., Guoli Town, Huantai County
Zibo,  CN 256400
Correspondent Contact Cindy Lee
Regulation Number880.6250
Classification Product Code
LZA  
Date Received09/28/2023
Decision Date 12/15/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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