Biodegradable Powder Free Vinyl Examination Gloves Blue, Green and White Colors— 510(k) K213144
Substantially EquivalentShen Wei USA, Inc.
FDA 510(k) clearance K213144 for Biodegradable Powder Free Vinyl Examination Gloves Blue, Green and White Colors, Substantially Equivalent on 2021-12-22. Applicant: Shen Wei USA, Inc.. Device class: 1.
Clearance details
- Applicant
- Shen Wei USA, Inc.
- Product code
- Code LYZ
- 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 LYZ
view allMore 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
- 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
- K202085 — Biodegradable Powder Free Neoprene Examination Glove, Low Dermatitis Potential Claim, Green
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