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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 K992100
Device Name PVC (POLYVINYL CHLORIDE) SYNTHETIC EXAMINATION GLOVES, POWDERED
Applicant
SHANGHAI PALOMAR MOUNTAIN INDUSTRIES, INC.
#1 BIYU RD., CANGQIAO TOWNSHIP
SONGJIANG SHANGHAI,  CN
Applicant Contact DANNY WANG
Correspondent
SHANGHAI PALOMAR MOUNTAIN INDUSTRIES, INC.
#1 BIYU RD., CANGQIAO TOWNSHIP
SONGJIANG SHANGHAI,  CN
Correspondent Contact DANNY WANG
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received06/21/1999
Decision Date 07/29/1999
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
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