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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 K041041
Device Name NON STERILE SYNTHETIC POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES
Applicant
Shanghai Foremost Plastic Industrial Co., Ltd.
13900 49th St. N.
Clearwater,  FL  33762
Applicant Contact WILLIAM E HARRIS
Correspondent
Entela, Inc.
3033 Madison Ave., SE
Grand Rapids,  MI  49548
Correspondent Contact NEIL E DEVINE
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received04/22/2004
Decision Date 06/08/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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