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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 K162381
Device Name HG PRO XP Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs
Applicant
Healthy Glove Co., Ltd.
119 Kanchanavanich Rd., Tambol Patong
Hat Yai,  TH 90230
Applicant Contact Teoh Choh Shee
Correspondent
Healthy Glove Co., Ltd.
119 Kanchanavanich Rd., Tambol Patong
Hat Yai,  TH 90230
Correspondent Contact Teoh Choh Shee
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Code
LZC  
Date Received08/24/2016
Decision Date 01/31/2017
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
Predetermined Change
Control Plan Authorized		 No
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