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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 K893076
Device Name PROSON PATIENT EXAMINATION GLOVES
Applicant
Long Far Industry Co., Ltd.
16 Ren Yih Ln. Heh Ming
Village Shiow
Shoei Hsiang Changhu,  TW
Applicant Contact KAREN LIM
Correspondent
Long Far Industry Co., Ltd.
16 Ren Yih Ln. Heh Ming
Village Shiow
Shoei Hsiang Changhu,  TW
Correspondent Contact KAREN LIM
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/13/1989
Decision Date 07/31/1989
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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