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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 K894013
Device Name NON-STERILE LATEX EXAMINATION GLOVES
Applicant
Nova Rubber Glove Industries Sdn. Bhd.
30a, Jalan Ss 20/10, Damansara
Kim, 47400 Petaling Jaya
Selangor, West Malaysia,  MY
Applicant Contact CHENG CHUAN
Correspondent
Nova Rubber Glove Industries Sdn. Bhd.
30a, Jalan Ss 20/10, Damansara
Kim, 47400 Petaling Jaya
Selangor, West Malaysia,  MY
Correspondent Contact CHENG CHUAN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received06/06/1989
Decision Date 08/21/1989
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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