21 CFR 880.6890 — Disinfectant, Medical Devices
General Hospital (HO) · Part 880 Subpart G—General Hospital and Personal Use Miscellaneous Devices · § 880.6890
Identification
A general purpose disinfectant is a germicide intended to process noncritical medical devices and equipment surfaces. A general purpose disinfectant can be used to preclean or decontaminate critical or semicritical medical devices prior to terminal sterilization or high level disinfection. Noncritical medical devices make only topical contact with intact skin.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| LRJ | Disinfectant, Medical Devices | 1 | 73 | |
| PWU | Clean-Up Kit | 1 | 0 | |
| PXG | Spill Kit | 1 | 0 | |
| PXM | Vomitus Clean-Up Kit | 1 | 0 |
