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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 K892096
Device Name PATIENT EXAMINATION GLOVE (LATEX)
Applicant
Grand Universe Trading Co., Ltd.
Rm. 3706 Singga Commercial
Center, 148 Connaught Rd. W.
Hong Kong,  HK
Applicant Contact ALFRED TONG
Correspondent
Grand Universe Trading Co., Ltd.
Rm. 3706 Singga Commercial
Center, 148 Connaught Rd. W.
Hong Kong,  HK
Correspondent Contact ALFRED TONG
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/03/1989
Decision Date 04/25/1989
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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