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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 K940387
Device Name SHIELDTEX STERILE PATIENT EXAMINATION GLOVES
Applicant
Shieldtex Sdn Bhd
Lot 7, Jalan Lada Sulah(16/11,
400000 Shah Alam,
Selangor, Malaysia,  MY
Applicant Contact B S TAN
Correspondent
Shieldtex Sdn Bhd
Lot 7, Jalan Lada Sulah(16/11,
400000 Shah Alam,
Selangor, Malaysia,  MY
Correspondent Contact B S TAN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received01/21/1994
Decision Date 03/11/1994
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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