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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 K030094
Device Name DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR
Applicant
Shanghai Palomar Mountain Industries, Inc.
18709 Greenbay Dr.
Rowland Heights,  CA  91748
Applicant Contact GLORIA CHANG
Correspondent
Shanghai Palomar Mountain Industries, Inc.
18709 Greenbay Dr.
Rowland Heights,  CA  91748
Correspondent Contact GLORIA CHANG
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received01/10/2003
Decision Date 04/01/2003
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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