COMFIT, PATIENT EXAMINATION GLOVES— 510(k) K903746
Substantially EquivalentWembley Rubber Products (M) Sdn Bhd
FDA 510(k) clearance K903746 for COMFIT, PATIENT EXAMINATION GLOVES, Substantially Equivalent on 1990-09-05. Applicant: Wembley Rubber Products (M) Sdn Bhd. Device class: 1.
Clearance details
- Applicant
- Wembley Rubber Products (M) Sdn Bhd
- 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
- Kuala Lumpur, 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)
More clearances from Wembley Rubber Products (M) Sdn Bhd
view all- K982600 — PROFEEL SYNTHETIC COPOLYMER SURGICAL GLOVES (POWDERED)
- K972616 — ONCOLOGY PLUS POWDER FREE LATEX EXAMINATION GLOVES (PROTEIN CONTENT LABELING)
- K972615 — CHEMO PLUS POWDER FREE BLUE LATEX EXAMINATION GLOVES (PROTEIN CONTENT LABELING)
- K972621 — PROFEEL POWDER FREE SURGICAL GLOVES (PROTEIN CONTENT LABELING)
- K953213 — COMFIT (POWDER FREE EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN, BEADED)
Data sourced from openFDA. This site is unofficial and independent of the FDA.