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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 K891644
Device Name SAMBORD LATEX PATIENT EXAMINATION GLOVES
Applicant
Polymint Industrial Co. , Ltd.
1-56, Hsin Chuang Tzae Ln.
Chung Sha Rd., Lung Ching
Hsiang, Taichung Hsien,  TW
Applicant Contact CHAN-LONG LIN
Correspondent
Polymint Industrial Co. , Ltd.
1-56, Hsin Chuang Tzae Ln.
Chung Sha Rd., Lung Ching
Hsiang, Taichung Hsien,  TW
Correspondent Contact CHAN-LONG LIN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/17/1989
Decision Date 06/19/1989
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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