FDA 510(k) Application Details - K032783

Device Classification Name Vinyl Patient Examination Glove

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510(K) Number K032783
Device Name Vinyl Patient Examination Glove
Applicant ZIBO BLUE SAIL PLASTIC & RUBBER PRODUCTS CO., LTD.
RM 707, AVIC BLDG., NO. 2
DONG SAN HUAN NAN ROAD
CHAOYANG DISTRICT, BEIJING 100022 CN
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Contact CHEN YUHONG
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Regulation Number 880.6250

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Classification Product Code LYZ
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Date Received 09/08/2003
Decision Date 11/13/2003
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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