Polychloroprene Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Fusion Colour)— 510(k) K211758
Substantially EquivalentHartalega NGC Sdn. Bhd.
FDA 510(k) clearance K211758 for Polychloroprene Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Fusion Colour), Substantially Equivalent on 2021-08-03. Applicant: Hartalega NGC Sdn. Bhd.. Device class: 1.
Clearance details
- Applicant
- Hartalega NGC Sdn. Bhd.
- Product code
- Code OPC
- Device class
- Class 1
- Regulation
- 21 CFR 880.6250
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sepang, MY
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Data sourced from openFDA. This site is unofficial and independent of the FDA.