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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 K964819
Device Name SHENG HO
Applicant
Shang HO Industrial Corp. , Ltd.
4-5 Nan Pei 1st. Rd.
Chiang Li Tachia
Taichung Hsien,  TW
Applicant Contact CHENG KO LIN
Correspondent
Shang HO Industrial Corp. , Ltd.
4-5 Nan Pei 1st. Rd.
Chiang Li Tachia
Taichung Hsien,  TW
Correspondent Contact CHENG KO LIN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received12/02/1996
Decision Date 01/06/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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