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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 K081539
Device Name DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR
Applicant
Rich Mountain Medical Products, Inc.
# 8, Jiang Yin Rd.
Yi Tang Township
Pizhou, Jiangsu,  CN
Applicant Contact MICHELLE SHIH
Correspondent
Rich Mountain Medical Products, Inc.
# 8, Jiang Yin Rd.
Yi Tang Township
Pizhou, Jiangsu,  CN
Correspondent Contact MICHELLE SHIH
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received06/02/2008
Decision Date 09/26/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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