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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 K892611
Device Name PATIENT EXAMINATION GLOVES (LATEX)
Applicant
Yty Industry (Manjung) Sdn Bhd
Lot 30, Jalan Lada Hitam 16/12
40000 Shah Alam
Selangor, Malaysia,  MY
Applicant Contact CHING SIEW
Correspondent
Yty Industry (Manjung) Sdn Bhd
Lot 30, Jalan Lada Hitam 16/12
40000 Shah Alam
Selangor, Malaysia,  MY
Correspondent Contact CHING SIEW
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/10/1989
Decision Date 07/14/1989
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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