STERILE POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS)— 510(k) K003653
Substantially EquivalentWrp Asia Pacific Sdn. Bhd.
FDA 510(k) clearance K003653 for STERILE POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS), Substantially Equivalent on 2001-01-26. Applicant: Wrp Asia Pacific Sdn. Bhd.. Device class: 1.
Clearance details
- Applicant
- Wrp Asia Pacific 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
- Salak Tinggi, Sepang Selangor, MY
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Data sourced from openFDA. This site is unofficial and independent of the FDA.