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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vinyl Patient Examination Glove
510(k) Number K934536
Device Name VINYL EXAMINATION GLOVES (NON STERILE)
Applicant
Arista Latindo Industrial Ltd. P.T
Jl: K.H.Moh Mansyur # 128
Jakarta,  ID 11210
Applicant Contact GENTHO SUMARTA
Correspondent
Arista Latindo Industrial Ltd. P.T
Jl: K.H.Moh Mansyur # 128
Jakarta,  ID 11210
Correspondent Contact GENTHO SUMARTA
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received09/20/1993
Decision Date 06/23/1994
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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