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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 K031142
Device Name DISPOSABLE POWDERED VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR
Applicant
Shanghai Palomar Mountain Industries, Inc.
#1 Biyu Rd., Cangqiao Township
Songjiang Shanghai,  CN 201600
Applicant Contact DANNY WANG
Correspondent
Shanghai Palomar Mountain Industries, Inc.
#1 Biyu Rd., Cangqiao Township
Songjiang Shanghai,  CN 201600
Correspondent Contact DANNY WANG
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received09/04/2003
Decision Date 03/17/2004
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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