AURELIA CHLORINATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH ALOE VERA AND GINSENG WITH PROTEIN LABELING CLAIM— 510(k) K013953
Substantially EquivalentSupermax Glove Manufacturing Sdn Bhd
FDA 510(k) clearance K013953 for AURELIA CHLORINATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH ALOE VERA AND GINSENG WITH PROTEIN LABELING CLAIM, Substantially Equivalent on 2002-02-26. Applicant: Supermax Glove Manufacturing Sdn Bhd. Device class: 1.
Clearance details
- Applicant
- Supermax Glove Manufacturing 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
- Sungai Buloh, Selangor, MY
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More clearances from Supermax Glove Manufacturing Sdn Bhd
view all- K024083 — GREEN POWDER FREE NITRILE MEDICAL EXAMINATION GLOVES WITH PEPPERMINT FLAVOR
- K014230 — STERILE POWDER FREE LATEX SURGEON GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS)
- K013589 — CHLORINATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH ALOE VERA
- K010198 — STERILE POWDERED LATEX SURGEON GLOVES
- K000644 — SUPERGLOVES STERILE POWDERED LATEX EXAMINATION GLOVES
Data sourced from openFDA. This site is unofficial and independent of the FDA.