Nitrile Powder Free Examination Gloves with Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid— 510(k) K243133
Substantially EquivalentKl-Kepong Rubber Products Sdn. Bhd.
FDA 510(k) clearance K243133 for Nitrile Powder Free Examination Gloves with Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid, Substantially Equivalent on 2025-06-17. Applicant: Kl-Kepong Rubber Products Sdn. Bhd.. Device class: 1.
Clearance details
- Applicant
- Kl-Kepong Rubber Products Sdn. Bhd.
- Product code
- Product code LZA
- Device class
- Class 1
- Regulation
- 21 CFR 880.6250
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ipoh, MY
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More clearances from Kl-Kepong Rubber Products Sdn. Bhd.
view allAdverse events under product code LZA
product code LZA- Other
- 1
- Total
- 1
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.