FDA 510(k) Application Details - K021853

Device Classification Name Vinyl Patient Examination Glove

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510(K) Number K021853
Device Name Vinyl Patient Examination Glove
Applicant SHANGHAI ANTARES INDUSTRIES, INC.
259 YUSHU RD.,
CANGQIAO TOWNSHIP
SONGJIANG COUNTY, SHANGHAI 201600 CN
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Contact JOHN LAI
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Regulation Number 880.6250

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Classification Product Code LYZ
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Date Received 06/06/2002
Decision Date 08/01/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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