FDA 510(k) Application Details - K211758

Device Classification Name	Powder-Free Polychloroprene Patient Examination Glove   More FDA Info for this Device
510(K) Number	K211758
Device Name	Powder-Free Polychloroprene Patient Examination Glove
Applicant	Hartalega Ngc Sdn. Bhd. No.1 Persiaran Tanjung Sepang 43900 MY Other 510(k) Applications for this Company
Contact	Kuan Mun Leong Other 510(k) Applications for this Contact
Regulation Number	880.6251   More FDA Info for this Regulation Number
Classification Product Code	OPC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/07/2021
Decision Date	08/03/2021
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