STERILE POWDERED LATEX SURGEON GLOVES— 510(k) K010198
Substantially EquivalentSupermax Glove Manufacturing Sdn Bhd
FDA 510(k) clearance K010198 for STERILE POWDERED LATEX SURGEON GLOVES, Substantially Equivalent on 2001-02-23. Applicant: Supermax Glove Manufacturing Sdn Bhd. Device class: 1.
Clearance details
- Applicant
- Supermax Glove Manufacturing Sdn Bhd
- Product code
- Code KGO
- Device class
- Class 1
- Regulation
- 21 CFR 878.4460
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- 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)
- K013953 — AURELIA CHLORINATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH ALOE VERA AND GINSENG WITH PROTEIN LABELING CLAIM
- K013589 — CHLORINATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH ALOE VERA
- K000644 — SUPERGLOVES STERILE POWDERED LATEX EXAMINATION GLOVES
Data sourced from openFDA. This site is unofficial and independent of the FDA.