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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 K921799
Device Name PATIENT EXAMINATION GLOVES
Applicant
Consolex Corp. Sdn. Bhd.
Jalan Keluli 15/16 Off, Off
Jalan Pesiaran Selangor, 40000
Shah Alar Darul Ehsan Mal,  MG
Applicant Contact 2A,
Correspondent
Consolex Corp. Sdn. Bhd.
Jalan Keluli 15/16 Off, Off
Jalan Pesiaran Selangor, 40000
Shah Alar Darul Ehsan Mal,  MG
Correspondent Contact 2A,
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/10/1992
Decision Date 07/08/1992
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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