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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 K171093
Device Name STERILE NITRILE PATIENT EXAMINATION GLOVES, POWDERFREE
Applicant
Sanrea Healthcare Products Pvt, Ltd.
Plot#P-56, Pearl Rd., Kinfra Iit Park, Kanjikode
Palakkad,  IN 678 621
Applicant Contact JOSE PAUL M.
Correspondent
Sanrea Healthcare Products Pvt, Ltd.
Plot#P-56, Pearl Rd., Kinfra Iit Park, Kanjikode
Palakkad,  IN 678 621
Correspondent Contact JOSE PAUL M.
Regulation Number880.6250
Classification Product Code
LZA  
Date Received04/12/2017
Decision Date 07/19/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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