Medical Gowns With Chemotherapy Labeling Claims - Tested For Use With Chemotherapy Drugs

QSO · Class II — Moderate Risk (510(k) clearance required) · General, Plastic Surgery · 21 CFR 878.4040

Classification

FDA Product Code: QSO
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 878.4040
Review panel: HO
Medical specialty: General, Plastic Surgery
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

Medical gowns that are worn by healthcare personnel to protect both the patient and the wearer from transfer of microorganisms, body fluids, and particulate material. In addition, these gowns have been tested for permeation and breakthrough resistance against various concentrations and types of chemotherapy drugs.

Market data

Cleared 510(k) submissions: 0
Registered establishments: 6

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown