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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 K010486
Device Name POLYMER COATED POWDER-FREE GREY COLOR POLYCHLOROPRENE PATIENT EXAMINATION GLOVES
Applicant
Pt. Medisafe Technologies
Jl. Let-Jen. S. Parman
# 23/235
Medan,  ID 20153
Applicant Contact ANIL TANEJA
Correspondent
Pt. Medisafe Technologies
Jl. Let-Jen. S. Parman
# 23/235
Medan,  ID 20153
Correspondent Contact ANIL TANEJA
Regulation Number880.6250
Classification Product Code
LZA  
Date Received02/20/2001
Decision Date 04/10/2001
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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