FDA 510(k) Application Details - K000670

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K000670
Device Name	Polymer Patient Examination Glove
Applicant	SHASTA ASIA PARTNERS GLOVES MANUFACTURING CO LTD. 198 AVENUE DE D'EMERALD SPARKS, NV 89434 US Other 510(k) Applications for this Company
Contact	JANNA P TUCKER 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	02/28/2000
Decision Date	04/12/2000
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