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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 K900149
Device Name POWDER-FREE VINYL GLOVES
Applicant
Good Glove Corp.
P.O. Box 5-119
Kaohsiung, Taiwan R.O.C.,  TW
Applicant Contact MAX MA
Correspondent
Good Glove Corp.
P.O. Box 5-119
Kaohsiung, Taiwan R.O.C.,  TW
Correspondent Contact MAX MA
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received01/11/1990
Decision Date 03/09/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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