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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 K891285
Device Name PATIENT EXAMINATION GLOVES (LATEX)
Applicant
Buildvest Holdings Sdn Bhd
No: 56 Jalan Ss 22/21
Damansara Jaya Town Centre
47400 Petaling Jaya, Sel.,  MY
Applicant Contact ROBERT WONG
Correspondent
Buildvest Holdings Sdn Bhd
No: 56 Jalan Ss 22/21
Damansara Jaya Town Centre
47400 Petaling Jaya, Sel.,  MY
Correspondent Contact ROBERT WONG
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/09/1989
Decision Date 07/31/1989
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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