POWDER-FREE LATES EXAM GLOVES WITH PROTEIN CLAIM— 510(k) K955029
Substantially EquivalentShen Wei (Usa), Inc.
FDA 510(k) clearance K955029 for POWDER-FREE LATES EXAM GLOVES WITH PROTEIN CLAIM, Substantially Equivalent on 1996-01-23. Applicant: Shen Wei (Usa), Inc.. Device class: 1.
Clearance details
- Applicant
- Shen Wei (Usa), Inc.
- Product code
- Code LYY
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.