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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 K895194
Device Name LATEX PATIENT EXAMINATION GLOVES
Applicant
Waterwide Sdn. Bhd.
Lot 2 Jalan Beremban 15/12
40000 Shah Alam, Selangor
Darul Ehsan, Malaysia,  MY
Applicant Contact AH CHOO
Correspondent
Waterwide Sdn. Bhd.
Lot 2 Jalan Beremban 15/12
40000 Shah Alam, Selangor
Darul Ehsan, Malaysia,  MY
Correspondent Contact AH CHOO
Regulation Number880.6250
Classification Product Code
LYY  
Date Received08/11/1989
Decision Date 11/16/1989
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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