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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 K892299
Device Name PATIENT EXAMINATION GLOVES (LATEX)
Applicant
Tegas Setia Sdn Bhd
Lot 597 Sg Rasa Industrial
Area Jln Bt
Tiga Lama Klang Sl,  MY 41300
Applicant Contact ZAINAL SULAIMAN
Correspondent
Tegas Setia Sdn Bhd
Lot 597 Sg Rasa Industrial
Area Jln Bt
Tiga Lama Klang Sl,  MY 41300
Correspondent Contact ZAINAL SULAIMAN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/06/1989
Decision Date 04/28/1989
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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