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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 K894499
Device Name ARMOR, LATEX EXAMINATION GLOVES
Applicant
Prestige Manufacturing Snd Bhd
# 6 Jalan Mega Mandung
Kompleks Bandar, Batu 5
58200 Kuala Lumpur Malays,  MY
Applicant Contact SIEW HON
Correspondent
Prestige Manufacturing Snd Bhd
# 6 Jalan Mega Mandung
Kompleks Bandar, Batu 5
58200 Kuala Lumpur Malays,  MY
Correspondent Contact SIEW HON
Regulation Number880.6250
Classification Product Code
LYY  
Date Received07/19/1989
Decision Date 09/21/1989
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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