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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
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