Powder-Free Polychloroprene Examination Glove (Green Color) Tested for Use with Chemotherapy Drugs and Fentanyl— 510(k) K250342
Substantially EquivalentEncompass Industries Sdn. Bhd.
FDA 510(k) clearance K250342 for Powder-Free Polychloroprene Examination Glove (Green Color) Tested for Use with Chemotherapy Drugs and Fentanyl, Substantially Equivalent on 2025-07-08. Applicant: Encompass Industries Sdn. Bhd.. Device class: 1.
Clearance details
- Applicant
- Encompass Industries Sdn. Bhd.
- Product code
- 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
- Kemaman, MY
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More clearances from Encompass Industries 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.