SHARK GLOVES Blue Nitrile Examination Gloves Powder Free, INCONGLOVE Blue Nitrile Examination Gloves Powder Free— 510(k) K212308
Substantially EquivalentSrirungruang Global Co., Ltd.
FDA 510(k) clearance K212308 for SHARK GLOVES Blue Nitrile Examination Gloves Powder Free, INCONGLOVE Blue Nitrile Examination Gloves Powder Free, Substantially Equivalent on 2021-10-29. Applicant: Srirungruang Global Co., Ltd.. Device class: 1.
Clearance details
- Applicant
- Srirungruang Global Co., Ltd.
- 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
- Banbung, TH
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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.