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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 K011712
Device Name LATEX EXAMINATION GLOVES- POWDER FREE, BLUE
Applicant
Pt.Shamrock Manufacturing Corp.
889 S. Azusa Ave.
City Of Industry,  CA  91748
Applicant Contact EMMY TJOENG
Correspondent
Pt.Shamrock Manufacturing Corp.
889 S. Azusa Ave.
City Of Industry,  CA  91748
Correspondent Contact EMMY TJOENG
Regulation Number880.6250
Classification Product Code
LYY  
Date Received06/04/2001
Decision Date 07/17/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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