Surgical Apparel With Material Claims
QBW is the FDA product code for Surgical Apparel With Material Claims, a class II device type, regulated under 21 CFR 878.4040. FDA's definition for this code reads: "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...". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.
Classification record
- Product code
- QBW
- Device name
- Surgical Apparel With Material Claims
- FDA 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.
- Regulation
- 21 CFR 878.4040
- Device class
- Class II
- Review panel
- General, Plastic Surgery
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 1
- Ingested recalls
- 0
Clearances, product code QBW
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2018 | 1 |
Applicants with the most clearances
Product code QBW| Applicant | Clearances |
|---|---|
| Vestagen Protective Technologies, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeNo registered establishment in MDM’s records lists product code QBW.
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