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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 K925363
Device Name HYPOALLERGENIC MULTI-COMFORT EXAMINATION GLOVES
Applicant
Perusahaan Intan Emas Sdn. Bhd.
158,Jalan Selar,Taman Cantik
4 1/2 Miles, Jalan Cheras,
56100 Kuala Lumpur, Malaysia,  MY
Applicant Contact LONG NIEN
Correspondent
Perusahaan Intan Emas Sdn. Bhd.
158,Jalan Selar,Taman Cantik
4 1/2 Miles, Jalan Cheras,
56100 Kuala Lumpur, Malaysia,  MY
Correspondent Contact LONG NIEN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received10/22/1992
Decision Date 07/06/1993
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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