POWDER FREE STERILE LATEX EXAM RADIATION ATTENUATION GLOVES— 510(k) K121811
Substantially EquivalentShen Wei (Usa), Inc.
FDA 510(k) clearance K121811 for POWDER FREE STERILE LATEX EXAM RADIATION ATTENUATION GLOVES, Substantially Equivalent on 2012-11-21. Applicant: Shen Wei (Usa), Inc.. Device class: 1.
Clearance details
- Applicant
- Shen Wei (Usa), Inc.
- Product code
- Code LZC
- 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 LZC
view all- K252313 — Cardinal Health Nitrile Examination Gloves Extended Cuff
- K243959 — Powder Free Nitrile Examination Gloves (Violet, Black, Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Select Other Drugs
- K221157 — JR Medic
- K222449 — Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue)
- K220545 — Powder Free Nitrile Examination Gloves, Blue, Tested for use with Chemotherapy Drugs
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.