FDA 510(k) Application Details - K974443

Device Classification Name	Vinyl Patient Examination Glove   More FDA Info for this Device
510(K) Number	K974443
Device Name	Vinyl Patient Examination Glove
Applicant	P.T. LATEXINDO TOBAPERKASA JALAN RAYA BINJAI KM. 11. MEDAN ID Other 510(k) Applications for this Company
Contact	HENDRA RAMALI 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	11/25/1997
Decision Date	01/05/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review