POWDER FREE LATEX EXAMINATION GLOVES, NATURAL OR BLUE COLOUR AND WITH PROTEIN CONTENT LABELING CLAIM (50 UG OR LESS)— 510(k) K061551
Substantially EquivalentMedipure Corporation (M) Sdn. Bhd.
FDA 510(k) clearance K061551 for POWDER FREE LATEX EXAMINATION GLOVES, NATURAL OR BLUE COLOUR AND WITH PROTEIN CONTENT LABELING CLAIM (50 UG OR LESS), Substantially Equivalent on 2006-08-24. Applicant: Medipure Corporation (M) Sdn. Bhd.. Device class: 1.
Clearance details
- Applicant
- Medipure Corporation (M) Sdn. Bhd.
- 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
- Special
- Location
- Ipoh, Perak, MY
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