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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 K891942
Device Name PATIENT EXAM GLOVES (MFG. JENQ CHUAM INDUSTRIAL)
Applicant
Lc Saratoga International, Inc.
812 Charcot Ave.
San Jose,  CA  95131
Applicant Contact CHAU H CHUANG
Correspondent
Lc Saratoga International, Inc.
812 Charcot Ave.
San Jose,  CA  95131
Correspondent Contact CHAU H CHUANG
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/23/1989
Decision Date 05/08/1989
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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