STERILE AND NON-STERILE POWDER-FREE LATEX PATIENT EXAMINATION GLOVE, WITH EXTRACTABLE PROTEIN CONTENT LABELING CLAIM (50— 510(k) K062917
Substantially EquivalentWear Safe Malaysia Sdn. Bhd.
FDA 510(k) clearance K062917 for STERILE AND NON-STERILE POWDER-FREE LATEX PATIENT EXAMINATION GLOVE, WITH EXTRACTABLE PROTEIN CONTENT LABELING CLAIM (50, Substantially Equivalent on 2006-11-02. Applicant: Wear Safe Malaysia Sdn. Bhd.. Device class: 1.
Clearance details
- Applicant
- Wear Safe Malaysia 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
- Port Klang, Selangor, D.E., MY
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Data sourced from openFDA. This site is unofficial and independent of the FDA.