FDA product code QBW: Surgical Apparel With Material Claims
QBW is the FDA product code for surgical apparel with material claims. It is a Class II device, regulated under 21 CFR 878.4040 and reviewed by the General Hospital panel. FDA has cleared 1 510(k) submission under QBW. The average 510(k) review took 113 days (median 113).
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.
Classification
| Field | Value |
|---|---|
| Device name | Surgical Apparel With Material Claims |
| Device class | Class II |
| Regulation | 21 CFR 878.4040 |
| Review panel | HO — General Hospital |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
510(k) clearances per year for QBW
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 113 |
Compare with all 510(k) review times · Search every QBW clearance
Top QBW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Vestagen Protective Technologies, Inc. | 1 | 2018-05-18 |
Most recent QBW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K180217 | Vestagen Protective Technologies, Inc. | VESTEX Apparel | 2018-05-18 | 113 |
Recalls for QBW devices
openFDA lists no recalls for product code QBW.
Frequently asked questions
What is FDA product code QBW?
QBW is the FDA product code for surgical apparel with material claims. It is a Class II device, regulated under 21 CFR 878.4040 and reviewed by the General Hospital panel.
What device class is QBW?
Class II, regulation 21 CFR 878.4040. Typical premarket route: 510(k).
How long does a 510(k) take for product code QBW?
Across 1 cleared submissions the average was 113 days from receipt to decision (median 113).
Which companies have the most QBW clearances?
Vestagen Protective Technologies, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QBW
- Run a recall and safety report across every QBW manufacturer
- Watch product code QBW for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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