NITRILE POWDER-FREE PATIENT EXAMINATION GLOVES— 510(k) K962461
Substantially EquivalentShen Wei (Usa), Inc.
FDA 510(k) clearance K962461 for NITRILE POWDER-FREE PATIENT EXAMINATION GLOVES, Substantially Equivalent on 1996-08-14. Applicant: Shen Wei (Usa), Inc.. Device class: 1.
Clearance details
- Applicant
- Shen Wei (Usa), Inc.
- 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
- Union City, CA, US
Recent devices under product code LZA
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- K260794 — NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WITH LICORICE ROOT EXTRACT AND UREA, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, FENTANYL CITRATE, XYLAZINE HCl, AND GASTRIC ACID. OCEAN COLOR
- K262014 — PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam Gloves
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.