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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Polymer Patient Examination Glove
510(k) Number K980807
Device Name NITRILE EXAMNATION GLOVES- POWDERFREE (SMALL, MEDIUM AND LARGE)
Applicant
Pt. Eka Wira Asia
12110 E. Slauson Ave., Suite 3
Santa Fe Springs,  CA  90670
Applicant Contact EMMY TJOENG
Correspondent
Pt. Eka Wira Asia
12110 E. Slauson Ave., Suite 3
Santa Fe Springs,  CA  90670
Correspondent Contact EMMY TJOENG
Regulation Number880.6250
Classification Product Code
LZA  
Date Received02/25/1998
Decision Date 04/02/1998
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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