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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Patient Examination Glove
510(k) Number K885346
Device Name NON-STERILE VINYL GLOVES
Applicant
Daw Shin Industrial Co., Ltd.
11f. 52, Wu Fu 3rd Rd.
Kaohsiung,  TW 80119
Correspondent
Daw Shin Industrial Co., Ltd.
11f. 52, Wu Fu 3rd Rd.
Kaohsiung,  TW 80119
Regulation Number880.6250
Classification Product Code
FMC  
Date Received12/28/1988
Decision Date 01/18/1989
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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