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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 K893796
Device Name DISPOSABLE VINYL (PVC) EXAMINATION GLOVES
Applicant
Anmei Plastic & Rubber Products Co. , Ltd.
Shanyenzi, Anqian Rd.
Anshan
(P.R.C.) China,  CN
Applicant Contact LI HONG
Correspondent
Anmei Plastic & Rubber Products Co. , Ltd.
Shanyenzi, Anqian Rd.
Anshan
(P.R.C.) China,  CN
Correspondent Contact LI HONG
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received05/22/1989
Decision Date 09/12/1989
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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