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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 K991457
Device Name DISPOSABLE VINYL SYNTHETIC EXAM GLOVES, POWDER FREE
Applicant
Shanghai Palomar Mountain Industries, Inc.
#1 Biyu Rd.,Cangqiao Township
Songjiang County
Shanghai,  CN
Applicant Contact DANNY WANG
Correspondent
Shanghai Palomar Mountain Industries, Inc.
#1 Biyu Rd.,Cangqiao Township
Songjiang County
Shanghai,  CN
Correspondent Contact DANNY WANG
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received04/26/1999
Decision Date 07/01/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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