OMNIGRACE LATEX EXAMINATION GLOVE, POWDER-FREE; POLYMER COATED WITH PROTEIN CLAIM (50 MICROGRAMS OR LESS)— 510(k) K993419
Substantially EquivalentOmnigrace , Ltd.
FDA 510(k) clearance K993419 for OMNIGRACE LATEX EXAMINATION GLOVE, POWDER-FREE; POLYMER COATED WITH PROTEIN CLAIM (50 MICROGRAMS OR LESS), Substantially Equivalent on 1999-11-19. Applicant: Omnigrace , Ltd.. Device class: 1.
Clearance details
- Applicant
- Omnigrace , 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.