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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Latex Patient Examination Glove
510(k) Number K893095
Device Name STERILE PATIENT EXAMINATION GLOVES (LATEX)
Applicant
Asia Way Trading, Inc.
32107 Lindero Canyon Rd.
Suite 206
Westlake Village,  CA  91361
Applicant Contact BOBBY LIN
Correspondent
Asia Way Trading, Inc.
32107 Lindero Canyon Rd.
Suite 206
Westlake Village,  CA  91361
Correspondent Contact BOBBY LIN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/11/1989
Decision Date 09/11/1989
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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