FDA 510(k) Application Details - K243172

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K243172
Device Name	Polymer Patient Examination Glove
Applicant	O&M Halyard, Inc. 9120 Lockwood Blvd Mechanicsville, VA 23116 US Other 510(k) Applications for this Company
Contact	Caitlin Senter 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	09/30/2024
Decision Date	06/18/2025
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