510(k) K180217
K180217 is an FDA 510(k) premarket notification submitted by Vestagen Protective Technologies, Inc. for the device "VESTEX Apparel". The FDA issued a decision of Substantially Equivalent on May 18, 2018. The device falls under product code QBW (Surgical Apparel With Material Claims), a Class II device regulated under 21 CFR 878.4040.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 18, 2018
- Date Received
- January 25, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Surgical Apparel With Material Claims
- Device Class
- Class II
- Regulation Number
- 878.4040
- Review Panel
- HO
- Submission Type
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.