Nitrile Patient Examination Gloves (Tested for Use with Chemotherapy Drugs)— 510(k) K213051
Substantially EquivalentYunnan Huazhiyuan Medical Technology Co., Ltd.
FDA 510(k) clearance K213051 for Nitrile Patient Examination Gloves (Tested for Use with Chemotherapy Drugs), Substantially Equivalent on 2021-12-18. Applicant: Yunnan Huazhiyuan Medical Technology Co., Ltd.. Device class: 1.
Clearance details
- Applicant
- Yunnan Huazhiyuan Medical Technology Co., Ltd.
- 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
- Honghe Hani And Yi Autonomous Prefecture, CN
Recent devices under product code LZA
view all- K253508 — Powder Free Nitrite Examination Glove, Cobalt Blue. Violet Blue and White. Non-Sterile
- K262208 — Non-sterile, Powder Free Nitrile Examination Aloe Vera Green Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid +2 more
- K261793 — Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and Black Color)
- K262542 — Biodegradable Nitrile Powder Free Examination Glove, Green +1 more
- K260312 — Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim +1 more
More clearances from Yunnan Huazhiyuan Medical Technology Co., Ltd.
view allAdverse 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.