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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 K891506
Device Name FREEPINHO VINYL EXAM GLOVES
Applicant
Reliance Industrial Co., Ltd.
Rm. 5-2, # 155, Section 1
Keeung Rd.
Taipei,  TW
Applicant Contact CHARLES CHOU
Correspondent
Reliance Industrial Co., Ltd.
Rm. 5-2, # 155, Section 1
Keeung Rd.
Taipei,  TW
Correspondent Contact CHARLES CHOU
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received03/16/1989
Decision Date 04/26/1989
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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