FDA 510(k) Application Details - K213144

Device Classification Name	Vinyl Patient Examination Glove   More FDA Info for this Device
510(K) Number	K213144
Device Name	Vinyl Patient Examination Glove
Applicant	Shen Wei USA Inc. 33278 Central Ave Ste 102 Union City, CA 94587 US Other 510(k) Applications for this Company
Contact	Cheryl Reep Other 510(k) Applications for this Contact
Regulation Number	880.6250   More FDA Info for this Regulation Number
Classification Product Code	LYZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/27/2021
Decision Date	12/22/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review