OMNI PRO LATEX SURGICAL GLOVE, POWDERED— 510(k) K982613
Substantially EquivalentOmnigrace (Thailand) , Ltd.
FDA 510(k) clearance K982613 for OMNI PRO LATEX SURGICAL GLOVE, POWDERED, Substantially Equivalent on 1998-09-02. Applicant: Omnigrace (Thailand) , Ltd.. Device class: 1.
Clearance details
- Applicant
- Omnigrace (Thailand) , Ltd.
- 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
- Hatyai, Songkhla, TH
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Data sourced from openFDA. This site is unofficial and independent of the FDA.