Browse hierarchy: [General Hospital (HO)](/submissions/HO) → [Subpart G — General Hospital and Personal Use Miscellaneous Devices](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices) → [21 CFR 880.6891](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/880.6891) → SHM — Interim Reprocessing Cleaning And Intermediate-Level Disinfection Wipe

# SHM · Interim Reprocessing Cleaning And Intermediate-Level Disinfection Wipe

_General Hospital · 21 CFR 880.6891 · Class 2_

**Canonical URL:** https://fda.innolitics.com/productcode/SHM

## Overview

- **Product Code:** SHM
- **Device Name:** Interim Reprocessing Cleaning And Intermediate-Level Disinfection Wipe
- **Regulation:** [21 CFR 880.6891](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/880.6891)
- **Device Class:** 2
- **Review Panel:** [General Hospital](/submissions/HO)

## Identification

Prolystica Pass Thru Disinfectant Wipes are a ready-to-use (RTU) one-step cleaner and intermediate level disinfectant. They are intended for use in hospitals and other healthcare facilities to clean and intermediate level disinfect non-submersible and/or heat-sensitive critical and semi-critical medical devices or medical device components as an interim step prior to sterilization or high-level disinfection. They are not intended for use on flexible endoscopes or as a terminal sterilization or high-level disinfection processing step.

## Classification Rationale

FDA has determined that the device can be classified in Class II with the establishment of special controls. Class II (special) controls provide reasonable assurance of the safety and effectiveness of the device type.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [DEN240075](/device/DEN240075.md) | Prolystica Pass Thru Disinfectant Wipes | Steris | May 1, 2026 | DENG |

## Top Applicants

- Steris — 1 clearance

---

**Source:** [https://fda.innolitics.com/productcode/SHM](https://fda.innolitics.com/productcode/SHM)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com