Powder Free Nitrile Examination Gloves Non-Sterile Black— 510(k) K253824
Substantially EquivalentKanglongda Vietnam Protection Technology Company Limited
FDA 510(k) clearance K253824 for Powder Free Nitrile Examination Gloves Non-Sterile Black, Substantially Equivalent on 2026-06-18. Applicant: Kanglongda Vietnam Protection Technology Company Limited. Device class: 1.
Summary
Kanglongda Vietnam Protection Technology's clearance covers black, non-sterile, powder-free nitrile examination gloves, filed under LZA, polymer patient examination gloves. The record gives no sizes.
Class I, 21 CFR 880.6250. General Hospital is both the classification panel and the review panel. The submission was a Traditional 510(k).
Kanglongda filed from Hue City, Vietnam. Review took 199 calendar days (December 1, 2025 to June 18, 2026).
Clearance details
- Applicant
- Kanglongda Vietnam Protection Technology Company Limited
- 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
- Hue City, VN
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More clearances from Kanglongda Vietnam Protection Technology Company Limited
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.