510(k) K211758
- Device
- Polychloroprene Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Fusion Colour)
- Applicant
- Hartalega NGC Sdn. Bhd.
- 510(k) number
- K211758
- Product code
- OPC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-08-03
- Date received
- 2021-06-07
- Regulation
- 880.6250
- Classification name
- Powder-Free Polychloroprene Patient Examination Glove
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- Kuan Mun Leong
- Address
- # 1 Persiaran Tanjung Sepang MY 43900 43900
FDA Registration Numbers#
- 3014384460
- 3019769825
- 3011200663
- 2183301
Source Documents#
510(k) summary PDF not indicated by FDA