FDA 510(k) Application Details - K093439

Device Classification Name	Vinyl Patient Examination Glove   More FDA Info for this Device
510(K) Number	K093439
Device Name	Vinyl Patient Examination Glove
Applicant	TANGSHAN PUFA PLASTIC PRODUCTS CO., LTD. 12390 EAST END AVENUE CHINO, CA 91710 US Other 510(k) Applications for this Company
Contact	JOHN ZHAO 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	11/04/2009
Decision Date	12/22/2009
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