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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 K011231
Device Name CHLORINATED POWDERED LATEX EXAMINATION GLOVES, BLUE, GREEN
Applicant
Protection Gloves Sdn. Bhd.
Lot # 236, Batu 2 1/2,
Jalan Yong Peng
Chaah, Johor,  MY 85400
Applicant Contact RICHARD CHOOI
Correspondent
Protection Gloves Sdn. Bhd.
Lot # 236, Batu 2 1/2,
Jalan Yong Peng
Chaah, Johor,  MY 85400
Correspondent Contact RICHARD CHOOI
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/23/2001
Decision Date 06/13/2001
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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