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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 K042214
Device Name POWDER-FREE NON-STERILE VINYL EXAMINATION GLOVES
Applicant
Shandong Perfect Plastic Co., Ltd.
55 Northern Blvd., Suite 200
Great Neck,  NY  11021
Applicant Contact ALAN P SCHWARTZ
Correspondent
Shandong Perfect Plastic Co., Ltd.
55 Northern Blvd., Suite 200
Great Neck,  NY  11021
Correspondent Contact ALAN P SCHWARTZ
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received08/16/2004
Decision Date 09/15/2004
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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