POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELLING CLAIM, CONTAINS 50 MICROGRAMS OR LESS OF TOTA— 510(k) K001529
Substantially EquivalentPerusahaan Getah Asas Sdn. Bhd.
FDA 510(k) clearance K001529 for POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELLING CLAIM, CONTAINS 50 MICROGRAMS OR LESS OF TOTA, Substantially Equivalent on 2000-06-12. Applicant: Perusahaan Getah Asas Sdn. Bhd.. Device class: 1.
Clearance details
- Applicant
- Perusahaan Getah Asas 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
- Selangor, MY
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Data sourced from openFDA. This site is unofficial and independent of the FDA.