FDA 510(k) Application Details - K024026

Device Classification Name Vinyl Patient Examination Glove

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510(K) Number K024026
Device Name Vinyl Patient Examination Glove
Applicant SHANGHAI PM PLASTICS ENTERISE CO., LTD.
258 YUSHU RD.
CANGQIAO TOWNSHIP
SHONGJIANG COUNTY, SHANGHAI 201600 CN
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Contact CHANG TE SUN
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Regulation Number 880.6250

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Classification Product Code LYZ
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Date Received 12/06/2002
Decision Date 12/18/2002
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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