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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 K892973
Device Name LATEX NON-STERILE PATIENT EXAMINATION GLOVES
Applicant
Polikon Trading Co.
Rm. 1002, 26-30 Des Voeux Rd.
West
Hong Kong,  HK
Applicant Contact NG
Correspondent
Polikon Trading Co.
Rm. 1002, 26-30 Des Voeux Rd.
West
Hong Kong,  HK
Correspondent Contact NG
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/12/1989
Decision Date 08/31/1989
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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