FDA 510(k) Application Details - K112743

Device Classification Name	Vinyl Patient Examination Glove   More FDA Info for this Device
510(K) Number	K112743
Device Name	Vinyl Patient Examination Glove
Applicant	CLEAN MEDICAL MANFACTURING CO;LTD 18633 E. GALE AVE.#105 CITY OF INDUSTRY, CA 91748 US Other 510(k) Applications for this Company
Contact	AARON RICHARD Other 510(k) Applications for this Contact
Regulation Number	880.6250   More FDA Info for this Regulation Number
Classification Product Code	LYZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/21/2011
Decision Date	12/16/2011
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