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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Surgeon'S Gloves
510(k) Number K001274
Device Name LATEX SURGEON SURGEON'S GLOVES POWDER-FREE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
Applicant
Pt. Maja Agung Latexindo
889 S. Azusa Ave.
City Of Industry,  CA  91748
Applicant Contact EMMY TJOENG
Correspondent
Pt. Maja Agung Latexindo
889 S. Azusa Ave.
City Of Industry,  CA  91748
Correspondent Contact EMMY TJOENG
Regulation Number878.4460
Classification Product Code
KGO  
Date Received04/20/2000
Decision Date 06/23/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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