POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs— 510(k) K163146
Substantially EquivalentHebei Hongsen Plastics Technology Co, Ltd.
FDA 510(k) clearance K163146 for POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs, Substantially Equivalent on 2017-02-13. Applicant: Hebei Hongsen Plastics Technology Co, Ltd.. Device class: 1.
Clearance details
- Applicant
- Hebei Hongsen Plastics Technology Co, Ltd.
- 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
- Nangong, CN
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 Hebei Hongsen Plastics Technology Co, Ltd.
view all- K150340 — POWDER FREE Nitrile GLOVES (White), POWDER FREE Nitrile GLOVES (Cobalt Blue), POWDER FREE Nitrile GLOVES (Black), POWDER FREE Nitrile GLOVES (Ice Blue)
- K140989 — POWDER FREE NITRILE SURGICAL GLOVES, WHITE COLOR (BRAND NAME: TITANFINE)
- K140988 — POWDER FREE STERILE LATEX SURGICAL GLOVE, YELLOW COLOR (BRAND NAME: TITANFINE)
- K131440 — POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE
Data sourced from openFDA. This site is unofficial and independent of the FDA.