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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vinyl Patient Examination Glove
510(k) Number K893368
Device Name VINYL EXAMINATION GLOVES
Applicant
Chuan Ming Plastic Industrial Co. , Ltd.
42 Section 3, Chang Shi St.
Tainan
Taiwan, R.O.C.,  TW
Applicant Contact SHUN-FA WU
Correspondent
Chuan Ming Plastic Industrial Co. , Ltd.
42 Section 3, Chang Shi St.
Tainan
Taiwan, R.O.C.,  TW
Correspondent Contact SHUN-FA WU
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received04/25/1989
Decision Date 08/21/1989
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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