FDA 510(k) Application Details - K010875

Device Classification Name	Latex Patient Examination Glove   More FDA Info for this Device
510(K) Number	K010875
Device Name	Latex Patient Examination Glove
Applicant	HYCARE INTL. CO., LTD. 1001 SE 12TH TERRACE DEERFIELD BEACH, FL 33441 US Other 510(k) Applications for this Company
Contact	JOHN GRASSI Other 510(k) Applications for this Contact
Regulation Number	880.6250   More FDA Info for this Regulation Number
Classification Product Code	LYY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/23/2001
Decision Date	06/07/2001
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