OMNI GRACE LATEX EXAMINATION GLOVE, POWDER FREE, POLYMER COATED WITH PROTEIN CLAIM— 510(k) K012402
Substantially EquivalentOmnigrace (Thailand) , Ltd.
FDA 510(k) clearance K012402 for OMNI GRACE LATEX EXAMINATION GLOVE, POWDER FREE, POLYMER COATED WITH PROTEIN CLAIM, Substantially Equivalent on 2001-10-12. Applicant: Omnigrace (Thailand) , Ltd.. Device class: 1.
Clearance details
- Applicant
- Omnigrace (Thailand) , Ltd.
- Product code
- Code LYY
- Device class
- Class 1
- Regulation
- 21 CFR 880.6250
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- North Canton, OH, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.