FDA 510(k) Application Details - K211624

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K211624
Device Name	Polymer Patient Examination Glove
Applicant	USA Gloves 12505 Reed Rd Ste 110 Sugar Land, TX 77478 US Other 510(k) Applications for this Company
Contact	Zishan Momin 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	05/27/2021
Decision Date	12/18/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review