Powder Free White Sterilized Polyisoprene Surgical Gloves-Tested for Use with The Chemotherapy Drugs— 510(k) K200915
Substantially EquivalentGx Corporation Sdn Bhd
FDA 510(k) clearance K200915 for Powder Free White Sterilized Polyisoprene Surgical Gloves-Tested for Use with The Chemotherapy Drugs, Substantially Equivalent on 2021-07-09. Applicant: Gx Corporation Sdn Bhd. Device class: 1.
Clearance details
- Applicant
- Gx Corporation 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
- Klang, MY
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Data sourced from openFDA. This site is unofficial and independent of the FDA.