CHLORINATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH ALOE VERA— 510(k) K013589
Substantially EquivalentSupermax Glove Manufacturing Sdn Bhd
FDA 510(k) clearance K013589 for CHLORINATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH ALOE VERA, Substantially Equivalent on 2002-01-08. 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
Recent devices under product code LYY
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- K230573 — Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeling Claim (Contains 50 ug per dm2 of glove or less of Total Water Extractable Protein)
- K223298 — Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L)
- K222612 — Powder-Free Latex examination gloves
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
- 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.