Surgical Apparel With Material Claims
The Surgical Apparel with Material Claims consists of garments worn by operating room personnel during surgical procedures to protect both the surgical patient and OR staff from transfer of microorganisms, body fluids, and particulate material, distinguished by components that have been constructed, treated, modified, or coated with substances to enhance functionality such as fluid repellency, soil retention, or antimicrobial activity. It is classified as a Class 2 device under regulation 878.4040, requiring 510(k) premarket notification, falling within the General, Plastic Surgery (SU) medical specialty with General Hospital (HO) review. The product code is QBW. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QBW
- Device Class
- FDA class 2
- Regulation Number
- 878.4040
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- HO
- Submission Type
- 1
Device Characteristics
Definition
Surgical apparel with material claims are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Surgical apparel with material claims contain components that have been constructed, treated, modified, and/or coated with substances that are intended or known to create or enhance a functional element of the device. Examples include fluid repellency, soil retention, or antimicrobial activity.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K180217 | VESTEX Apparel | May 18, 2018 | Substantially Equivalent | Vestagen Protective Technologies, Inc. |