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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 K895340
Device Name ABTEX OR JUTAMAL LATEX EXAMINATION GLOVES
Applicant
Jutamal Industry
# 4l, Jalan Larkin
80200 Johore Bahru
Johore, Malaysia,  MY
Applicant Contact HAN LEE
Correspondent
Jutamal Industry
# 4l, Jalan Larkin
80200 Johore Bahru
Johore, Malaysia,  MY
Correspondent Contact HAN LEE
Regulation Number880.6250
Classification Product Code
LYY  
Date Received08/31/1989
Decision Date 11/16/1989
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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