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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 K994432
Device Name HWA & SILKTEX POWDERED LATEX EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING CLAIM (140 MICROGRAMS OR LESS)
Applicant
HWA TEH INDUSTRIAL SDN. BHD.
LOT 187, SUNGAI DAHAR
BATANG BERJUNTAI,  MY 45600
Applicant Contact K. KARUNAKARAN
Correspondent
HWA TEH INDUSTRIAL SDN. BHD.
LOT 187, SUNGAI DAHAR
BATANG BERJUNTAI,  MY 45600
Correspondent Contact K. KARUNAKARAN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received12/30/1999
Decision Date 02/16/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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