FDA 510(k) Application Details - K020044

Device Classification Name	Vinyl Patient Examination Glove   More FDA Info for this Device
510(K) Number	K020044
Device Name	Vinyl Patient Examination Glove
Applicant	PRIMUS GLOVES PRIVATE LTD. PLOT NO:14-A COCHIN SPECIAL ECONOMIC ZONE KAKKANAD, KOCHI, KERALA 682 030 IN Other 510(k) Applications for this Company
Contact	JOSEPH J E PEREIRA 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	01/07/2002
Decision Date	02/26/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review