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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 K915872
Device Name LATEX PATIENT EXAMINATION GLOVES
Applicant
Sri Anusham Rubber Industries Pvt., Ltd.
Pioneer Manikandan Bldg.,
Vadasery, Nagercoil 629 001
India,  IN
Applicant Contact PARAMASIVAN
Correspondent
Sri Anusham Rubber Industries Pvt., Ltd.
Pioneer Manikandan Bldg.,
Vadasery, Nagercoil 629 001
India,  IN
Correspondent Contact PARAMASIVAN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received12/05/1991
Decision Date 04/02/1992
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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