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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 K900092
Device Name MODIFIED SAFE VINYL EXAMINATION GLOVES
Applicant
Universal Gloves Corp.
Rm.5-2, # 155, Sec. 1
Keelung Rd., Taipei (10546)
Taiwan, R.O.C.,  TW
Applicant Contact CHARLES CHOU
Correspondent
Universal Gloves Corp.
Rm.5-2, # 155, Sec. 1
Keelung Rd., Taipei (10546)
Taiwan, R.O.C.,  TW
Correspondent Contact CHARLES CHOU
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received01/08/1990
Decision Date 03/08/1990
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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