FDA 510(k) Application Details - K000166

Device Classification Name	Vinyl Patient Examination Glove   More FDA Info for this Device
510(K) Number	K000166
Device Name	Vinyl Patient Examination Glove
Applicant	SHIJIAZHUANG GREAT EAGLE PLASTIC PRODUCTS CO., LTD 13945 MAGNOLIA AVE. CHINO, CA 91710 US Other 510(k) Applications for this Company
Contact	JAMES CHU 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	01/19/2000
Decision Date	02/22/2000
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