Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs (Natural)— 510(k) K221718
Substantially EquivalentHartalega NGC Sdn. Bhd.
FDA 510(k) clearance K221718 for Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs (Natural), Substantially Equivalent on 2022-09-24. Applicant: Hartalega NGC Sdn. Bhd.. Device class: 1.
Clearance details
- Applicant
- Hartalega NGC Sdn. Bhd.
- Product code
- Code KGO
- Device class
- Class 1
- Regulation
- 21 CFR 878.4460
- Advisory panel
- General, Plastic Surgery
- 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.