FDA 510(k) Application Details - K992860

Device Classification Name Vinyl Patient Examination Glove

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510(K) Number K992860
Device Name Vinyl Patient Examination Glove
Applicant SHIJIAZHUANG HONGRAY PLASTIC PRODUCTS CO., LTD.
NO. 135 XIN-HUA WEST ROAD
HIJIAZHUANG CITY
HEBEI PROVINCE 050081 CN
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Contact GUI-XI LIU
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Regulation Number 880.6250

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Classification Product Code LYZ
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Date Received 08/25/1999
Decision Date 09/24/1999
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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