FLOUROSHIELD RADIATION REDUCTION GLOVE— 510(k) K893093
Substantially EquivalentAcufex Microsurgical, Inc.
FDA 510(k) clearance K893093 for FLOUROSHIELD RADIATION REDUCTION GLOVE, Substantially Equivalent on 1990-02-13. Applicant: Acufex Microsurgical, Inc.. Device class: 1.
Clearance details
- Applicant
- Acufex Microsurgical, 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
- Norwood, MA, 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 Acufex Microsurgical, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.