FDA 510(k) Application Details - K010297

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K010297
Device Name	Polymer Patient Examination Glove
Applicant	MAXXIM MEDICAL 308 CHURCH ST HONEA PATH, SC 29654 US Other 510(k) Applications for this Company
Contact	WUNAN HUANG 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	01/31/2001
Decision Date	02/16/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review