Powder Free White, Green Sterilized Polychloroprene Copolymer Surgical Gloves - Tested for Use with Chemotherapy Drugs— 510(k) K180221
Substantially EquivalentSmart Glove Corporation Sdn. Bhd.
FDA 510(k) clearance K180221 for Powder Free White, Green Sterilized Polychloroprene Copolymer Surgical Gloves - Tested for Use with Chemotherapy Drugs, Substantially Equivalent on 2018-08-08. Applicant: Smart Glove Corporation Sdn. Bhd.. Device class: 1.
Clearance details
- Applicant
- Smart Glove 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.