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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 K914284
Device Name PATIENT EXAMINATION GLOVES
Applicant
K-International Exports Pvt. , Ltd.
2nd Floor , 138, Thambu Chetty St.
Madras-600001, Tami Nadu,
India,  IN
Applicant Contact MOHAMED KASIM
Correspondent
K-International Exports Pvt. , Ltd.
2nd Floor , 138, Thambu Chetty St.
Madras-600001, Tami Nadu,
India,  IN
Correspondent Contact MOHAMED KASIM
Regulation Number880.6250
Classification Product Code
LYY  
Date Received09/24/1991
Decision Date 12/23/1991
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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