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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 K894193
Device Name LATEX EXAMINATION GLOVES
Applicant
Hasil Getah Gulungan Pertama
Lot 17506, Jalan Dua, Taman,
Selayang Baru, Batu Caves,
68100, Selangor, Malaysia,  MY
Applicant Contact SUNIL JAYAWARDENA
Correspondent
Hasil Getah Gulungan Pertama
Lot 17506, Jalan Dua, Taman,
Selayang Baru, Batu Caves,
68100, Selangor, Malaysia,  MY
Correspondent Contact SUNIL JAYAWARDENA
Regulation Number880.6250
Classification Product Code
LYY  
Date Received06/12/1989
Decision Date 09/28/1989
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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