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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 K891307
Device Name PATIENT EXAMINATION GLOVES (LATEX)
Applicant
Five Star Rubber Products
21b Jalan Desa Jaya, Town Ctr.
Taman Desa Off Jalan Kelang
Lama 58100 Kuala Lumpur,  MY
Applicant Contact SING HWA
Correspondent
Five Star Rubber Products
21b Jalan Desa Jaya, Town Ctr.
Taman Desa Off Jalan Kelang
Lama 58100 Kuala Lumpur,  MY
Correspondent Contact SING HWA
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/13/1989
Decision Date 03/31/1989
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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