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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 K892788
Device Name PATIENT EXAMINATION GLOVES (LATEX)
Applicant
DAWIN INVESTMENTS LTD.
3/F, SINGGA COMMERCIAL
CENTRE, 144-151
CONNAUGHT RD. WEST,  HK
Applicant Contact DAVID C REINER
Correspondent
DAWIN INVESTMENTS LTD.
3/F, SINGGA COMMERCIAL
CENTRE, 144-151
CONNAUGHT RD. WEST,  HK
Correspondent Contact DAVID C REINER
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/11/1989
Decision Date 08/01/1989
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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