TEXTURED POWDER FREE NITRILE EXAM GLOVES WITH SAP— 510(k) K061756
Substantially EquivalentShen Wei (Usa), Inc.
FDA 510(k) clearance K061756 for TEXTURED POWDER FREE NITRILE EXAM GLOVES WITH SAP, Substantially Equivalent on 2007-04-19. Applicant: Shen Wei (Usa), Inc.. Device class: 1.
Clearance details
- Applicant
- Shen Wei (Usa), Inc.
- 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
- Union City, CA, US
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More clearances from Shen Wei (Usa), Inc.
view all- K213141 — Biodegradable Powder Free Nitrile Examination Glove, Blue and Green colors, Low Dermatitis Potential, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate-Simulated Gastric Acid Solution
- K213142 — Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and Gray Colors, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate Simulated Gastric Acid Solution
- K213144 — Biodegradable Powder Free Vinyl Examination Gloves Blue, Green and White Colors
- K211620 — Biodegradable Powder Free Latex Examination Gloves Natural, Blue, Black and Green Colors with protein content labeling claim (50 micrograms or less)
- K211455 — Powder Free Nitrile Examination Gloves with Aloe Vera, Orange and Orange-White Colors
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.