Identifiers
- 510(k) Number
- K925016 FDA 510(k)
- FDA Product Code
- LRO FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4370 FDA 510(k)
- Regulation Number
- 878.4370 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Prep Shave Kit (Non-Sterile) is a General Surgery Tray designed for preoperative hair removal in surgical preparation. It includes tools and supplies intended to facilitate safe and effective shaving of the patient’s skin prior to procedures, reducing the risk of contamination and improving surgical field visibility.
This kit is supplied in a non-sterile configuration and is intended for single-use in clinical settings such as operating rooms or preoperative areas. It carries an FDA 510(k) clearance (K925016) under the Substantially Equivalent (SESE) classification, with regulatory filing under product code LRO and reviewed by the General & Plastic Surgery Advisory Committee. Storage and handling should comply with standard non-sterile medical device protocols.
Frequently asked questions
What is the Prep Shave Kit (Non-Sterile) primarily used for in a clinical setting?
The Prep Shave Kit (Non-Sterile) is designed specifically for preoperative hair removal to prepare a patient’s skin before surgical procedures. Its purpose is to improve surgical field visibility and reduce contamination risks by safely and effectively removing hair prior to surgery in areas like operating rooms or preoperative areas.
Is this kit intended for reuse or single-use, and how should it be handled?
The kit is explicitly intended for single-use only in clinical settings. Since it is non-sterile, it should be handled according to standard non-sterile medical device protocols, ensuring proper storage and disposal after use to maintain hygiene and prevent cross-contamination.
How is the regulatory status of this device determined, and which committee reviewed it?
The Prep Shave Kit (Non-Sterile) holds an FDA 510(k) clearance (K925016) under the *Substantially Equivalent (SESE)* classification, meaning it was evaluated as comparable to a legally marketed device. The review was conducted under product code LRO and was assigned to the General & Plastic Surgery Advisory Committee (SU) for advisory input before clearance.
What type of environment is this kit designed for, and why is it non-sterile?
The kit is designed for non-sterile use in clinical environments like operating rooms or preoperative areas, where hair removal occurs before surgical procedures. It is non-sterile because it is not intended to enter a sterile field (e.g., during surgery) but rather to prepare the patient’s skin *prior* to the sterile phase, where other sterile instruments and drapes would then be applied.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PREP SHAVE KIT (NON-STERILE) 510 (k) K925016 - FDA.report, PDF K925016 - Prep Shave Kit (Non-sterile), Customed, Inc. FDA 510 (k) Products (1990-1998), IV PREP KIT (NON-STERILE) (K925017) — FDA 510(k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K925016 | Class II | Active |
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Manufacturer
- Manufacturer
- Customed, Inc.
Sources (1)
- FDA 510(k) K925016 24 fields · synced Sep 19, 2026