LATEX EXAMINATION GLOVES— 510(k) K893331
Substantially EquivalentP.T. Kencana Ronasakti Prima
FDA 510(k) clearance K893331 for LATEX EXAMINATION GLOVES, Substantially Equivalent on 1989-07-14. Applicant: P.T. Kencana Ronasakti Prima. Device class: 1.
Clearance details
- Applicant
- P.T. Kencana Ronasakti Prima
- 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
- Great Neck, NY, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.