Synthetic Polymer Glove - Polyethylene (Black)— 510(k) K222531
Substantially EquivalentUr Industry Sdn Bhd
FDA 510(k) clearance K222531 for Synthetic Polymer Glove - Polyethylene (Black), Substantially Equivalent on 2023-01-22. Applicant: Ur Industry Sdn Bhd. Device class: 1.
Clearance details
- Applicant
- Ur Industry 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
- Senai, MY
Recent devices under product code LZA
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- K262014 — PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam Gloves
Adverse 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.