O'Star Nitrile Examination Gloves Powder Free— 510(k) K213058
Substantially EquivalentStar Investment and Trade Joint Stock Company
FDA 510(k) clearance K213058 for O'Star Nitrile Examination Gloves Powder Free, Substantially Equivalent on 2022-02-08. Applicant: Star Investment and Trade Joint Stock Company. Device class: 1.
Clearance details
- Applicant
- Star Investment and Trade Joint Stock Company
- 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
- Bac Ninh, VN
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.