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FDA 510(k) Application Details - K070862
Device Classification Name
Polymer Patient Examination Glove
More FDA Info for this Device
510(K) Number
K070862
Device Name
Polymer Patient Examination Glove
Applicant
PURTECH CLEANROOM PRODUCTS CO., LTD.
3973 SCHAEFER AVE.
CHINO, CA 91789 US
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Contact
KATHY LIU
Other 510(k) Applications for this Contact
Regulation Number
880.6250
More FDA Info for this Regulation Number
Classification Product Code
LZA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/28/2007
Decision Date
05/30/2007
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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