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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 K111598
Device Name POWDER-FREE NON-STERILE VINYL EXAMINATION GLOVE
Applicant
Lpl (Hui Zhou) Glove Co., Ltd.
144 Research Dr.
Hampton,  VA  23666
Applicant Contact CAMILLE D THORNTON
Correspondent
Lpl (Hui Zhou) Glove Co., Ltd.
144 Research Dr.
Hampton,  VA  23666
Correspondent Contact CAMILLE D THORNTON
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received06/08/2011
Decision Date 07/20/2011
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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