BRIGHTWAY BRAND NITRILE SURGICAL GLOVES - STERILE (POWDERED)— 510(k) K991940
Substantially EquivalentBrightway Holdings Sdn. Bhd.
FDA 510(k) clearance K991940 for BRIGHTWAY BRAND NITRILE SURGICAL GLOVES - STERILE (POWDERED), Substantially Equivalent on 1999-07-12. Applicant: Brightway Holdings Sdn. Bhd.. Device class: 1.
Clearance details
- Applicant
- Brightway Holdings 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, Selangor Darul Ehsan, MY
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More clearances from Brightway Holdings Sdn. Bhd.
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- K162294 — BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12, POWDER FREE, [PURPLE] TESTED FOR USE WITH CHEMOTHERAPY DRUGS
- K162186 — BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12, POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM
- K163267 — NITRILE EXAMINATION GLOVE
Data sourced from openFDA. This site is unofficial and independent of the FDA.