Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue), Polyisoprene Powder Free Surgical Glove for Use with Chemotherapy Drugs (Natural)— 510(k) K200897
Substantially EquivalentHartalega Sdn Bhd
FDA 510(k) clearance K200897 for Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue), Polyisoprene Powder Free Surgical Glove for Use with Chemotherapy Drugs (Natural), Substantially Equivalent on 2020-06-01. Applicant: Hartalega Sdn Bhd.
Clearance details
- Applicant
- Hartalega Sdn Bhd
- Product code
- Code KGO
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bandar Sri Damansara, MY
Data sourced from openFDA. This site is unofficial and independent of the FDA.