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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 K892295
Device Name SEVACARE PATIENT EXAMINATION GLOVES
Applicant
Sevaids Industries
294, Perin Nariman St.
Haroon House 2nd Floor
Bombay-400 001, India,  IN
Applicant Contact SIDDHARTH SHAH
Correspondent
Sevaids Industries
294, Perin Nariman St.
Haroon House 2nd Floor
Bombay-400 001, India,  IN
Correspondent Contact SIDDHARTH SHAH
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/06/1989
Decision Date 07/14/1989
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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