BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12, POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM— 510(k) K162186
Substantially EquivalentBrightway Holdings Sdn. Bhd.
FDA 510(k) clearance K162186 for BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12, POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM, Substantially Equivalent on 2017-03-31. Applicant: Brightway Holdings Sdn. Bhd.. Device class: 1.
Clearance details
- Applicant
- Brightway Holdings Sdn. Bhd.
- Product code
- Code LZC
- Device class
- Class 1
- Regulation
- 21 CFR 880.6250
- Advisory panel
- General Hospital
- 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.