Product code QBW— General, Plastic Surgery
VESTEX Apparel
- Classification name
- Surgical Apparel With Material Claims
- Device class
- Class 2
- Regulation
- 21 CFR 878.4040
- Advisory panel
- General, Plastic Surgery
- Total cleared
- 1
- First cleared
- Most recent
FDA classification 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.”
Market context for product code QBW
FDA has cleared device under product code QBW, all in 2018, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Top applicants under product code QBW
Recent clearances under product code QBW
Data sourced from openFDA. This site is unofficial and independent of the FDA.