FDA 510(k) Application Details - K041225

Device Classification Name Vinyl Patient Examination Glove

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510(K) Number K041225
Device Name Vinyl Patient Examination Glove
Applicant GRAND WORK PLASTIC PRODUCTS CO., LTD.
DONGGAO INDUSTRIAL ZONE ZANHUANG
ZANHUANG COUNTY 050000 CN
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Contact JAMES CHU
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Regulation Number 880.6250

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Classification Product Code LYZ
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Date Received 05/10/2004
Decision Date 07/15/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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