FDA 510(k) Application Details - K972757

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K972757
Device Name	Polymer Patient Examination Glove
Applicant	SHIELD GLOVES MANUFACTURER (M) SDN BHD 87, 2ND FL., JALAN SS, 15/4-C, SUBANG JAYA PETALING JAYA, SELANGOR 47500 MY Other 510(k) Applications for this Company
Contact	ONG LAY MAU 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	07/23/1997
Decision Date	10/29/1997
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