LATEX EXAMINATION GLOVE— 510(k) K882533
Substantially EquivalentSukas Export
FDA 510(k) clearance K882533 for LATEX EXAMINATION GLOVE, Substantially Equivalent on 1988-07-21. Applicant: Sukas Export. Device class: 1.
Clearance details
- Applicant
- Sukas Export
- Product code
- Code FMC
- 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, Malaysia, MY
Recent devices under product code FMC
view all- K042618 — LAGLOVE BRAND DOUBLE POLYMER COATED NITRILE EXAMINATION GLOVES (POWDER FREE - BLUE COLOR)
- K014134 — POWDER-FREE LATEX EXAM GLOVES WITH PROTEIN LABELING (<50UG/G)
- K992337 — BLOSSOM POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM 50 MCGM OR LESS OF TOTAL WATER EXTRACTA
- K932404 — NITRILE RUBBER POWDER-FREE EXAMINATION GLOVE
- K932405 — NITRILE RUBBER EXAMINATION GLOVES (POWERED)
Data sourced from openFDA. This site is unofficial and independent of the FDA.