FDA 510(k) Application Details - K013254

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K013254
Device Name	Polymer Patient Examination Glove
Applicant	TOP QUALITY MFG., INC. 962 ALLEGRO LN. APOLLO BEACH, FL 33572 US Other 510(k) Applications for this Company
Contact	ART WARD 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	09/28/2001
Decision Date	02/04/2002
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