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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 K893724
Device Name EMAS GLOVE
Applicant
Exim Mfg. & Assoc. Services, Sdn Bhd
# 110, Jalan Bendahara,
P.O. Box 1258, 98008, Miri
Sarawak, East Malaysia,  MY
Applicant Contact MICHAEL NGUI
Correspondent
Exim Mfg. & Assoc. Services, Sdn Bhd
# 110, Jalan Bendahara,
P.O. Box 1258, 98008, Miri
Sarawak, East Malaysia,  MY
Correspondent Contact MICHAEL NGUI
Regulation Number880.6250
Classification Product Code
LYY  
Date Received05/17/1989
Decision Date 08/10/1989
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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