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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 K893338
Device Name VINYL EXAMINATION GLOVES
Applicant
Taiwan an Lih Ent. Co. , Ltd.
# 12, Shun Tien Rd., Ta Chia
Chen Tai Chung Hsien,  TW
Applicant Contact LONG SHI
Correspondent
Taiwan an Lih Ent. Co. , Ltd.
# 12, Shun Tien Rd., Ta Chia
Chen Tai Chung Hsien,  TW
Correspondent Contact LONG SHI
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received04/20/1989
Decision Date 09/15/1989
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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