FDA 510(k) Application Details - K101870

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K101870
Device Name	Polymer Patient Examination Glove
Applicant	SUNMAX VIETNAM CO. LTD 55 Northern Blvd Suite 200 Great Neck, NY 11021 US Other 510(k) Applications for this Company
Contact	JIGAR SHAH 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	07/06/2010
Decision Date	12/20/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review