WRP FOLEYCATH— 510(k) K903777
Substantially EquivalentWembley Rubber Products (M) Sdn Bhd
FDA 510(k) clearance K903777 for WRP FOLEYCATH, Substantially Equivalent on 1990-12-13. Applicant: Wembley Rubber Products (M) Sdn Bhd. Device class: 2.
Clearance details
- Applicant
- Wembley Rubber Products (M) Sdn Bhd
- Product code
- Code EZL
- Device class
- Class 2
- Regulation
- 21 CFR 876.5130
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Selangor, Malaysia, MY
Recent devices under product code EZL
view allMore 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)
Adverse events under product code EZL
product code EZL- Death
- 6
- Injury
- 796
- Malfunction
- 4,989
- Other
- 1
- Total
- 5,792
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.