PWS · Chemotherapy Administration Kit
General Hospital · 21 CFR 880.6250 · Class 1
Overview
| Product Code | PWS |
|---|---|
| Device Name | Chemotherapy Administration Kit |
| Regulation | 21 CFR 880.6250 |
| Device Class | Class 1 |
| Review Panel | General Hospital |
Identification
A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.
Classification Rationale
Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
