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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 K890851
Device Name PATIENT EXAMINATION GLOVES (NON-STERILE VINYL)
Applicant
Daw Shin Industrial Co., Ltd.
11f., 52, Wu Fu 3rd Rd.
Kaohsiung 80119
Taiwan,  TW
Applicant Contact MAX MA
Correspondent
Daw Shin Industrial Co., Ltd.
11f., 52, Wu Fu 3rd Rd.
Kaohsiung 80119
Taiwan,  TW
Correspondent Contact MAX MA
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received02/21/1989
Decision Date 04/25/1989
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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