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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 K892511
Device Name PATIENT EXAMINATION GLOVES (LATEX)
Applicant
Ampac Rubber Co., Ltd.
# 39, Sing-Yen Rd.
Sing-Kuon Subward Dou-Nan Town
Yun-Lin Shien, Taiwan,  TW
Applicant Contact DENNIS E LANE
Correspondent
Ampac Rubber Co., Ltd.
# 39, Sing-Yen Rd.
Sing-Kuon Subward Dou-Nan Town
Yun-Lin Shien, Taiwan,  TW
Correspondent Contact DENNIS E LANE
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/12/1989
Decision Date 05/12/1989
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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