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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 K891344
Device Name OLIVE BRAND, SILKY TOUCH PATIENT EXAMINATION GLOVE
Applicant
Uni-Attach, Inc.
# 6 Ln. 182 Sec. 1
Chun Hsan Rd., Taiping Country
Taichung Hiang, Taiwan,  TW
Applicant Contact MICHELLE LEE
Correspondent
Uni-Attach, Inc.
# 6 Ln. 182 Sec. 1
Chun Hsan Rd., Taiping Country
Taichung Hiang, Taiwan,  TW
Correspondent Contact MICHELLE LEE
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/10/1989
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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