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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 K892115
Device Name PROTEX PATIENT EXAMINATION GLOVES (LATEX)
Applicant
Pt Nusa Dipa Perdana
55 Northern Blvd.
Suite 205
Great Neck,  NY  11021
Applicant Contact ALAN P SCHWARTZ
Correspondent
Pt Nusa Dipa Perdana
55 Northern Blvd.
Suite 205
Great Neck,  NY  11021
Correspondent Contact ALAN P SCHWARTZ
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/04/1989
Decision Date 04/25/1989
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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