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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vinyl Patient Examination Glove
510(k) Number K993880
Device Name SHANGHAI GLOVMAX ENTERPRISE CO, LTD., POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
Applicant
Shanghai Glovmax Enterprise Co.,Ltd
Nanking E. Rd., Sec 3
Taipei,  TW
Applicant Contact MAO-SHENG LEE
Correspondent
Shanghai Glovmax Enterprise Co.,Ltd
Nanking E. Rd., Sec 3
Taipei,  TW
Correspondent Contact MAO-SHENG LEE
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received11/15/1999
Decision Date 01/12/2000
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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