POWDERED LATEX EXAM GLOVES, PROTEIN LABELING (150 MICROGRAM OR LESS)— 510(k) K001327
Substantially EquivalentPremier Pathway Sdn. Bhd.
FDA 510(k) clearance K001327 for POWDERED LATEX EXAM GLOVES, PROTEIN LABELING (150 MICROGRAM OR LESS), Substantially Equivalent on 2000-05-23. Applicant: Premier Pathway Sdn. Bhd.. Device class: 1.
Clearance details
- Applicant
- Premier Pathway 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
- Traditional
- Location
- Sparks, NV, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.