Zhejiang Hangkang Medical Equipment Co., Ltd. · Class II · Cleared Mar 3, 2026
| K-number | K252534 |
| Device name | Surgical Face Mask (Ear mount) |
| Applicant | Zhejiang Hangkang Medical Equipment Co., Ltd. |
| Product code | FXX |
| Device class | Class II |
| Decision date | Mar 3, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 878.4040 |
The Surgical Face Mask (Ear Mount) is a single-use, non-sterile disposable device intended to protect both patients and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. It is used in infection control practices to reduce potential exposure to blood and body fluids.
Not stated in this summary.
Not stated in this summary.
The device is determined to be substantially equivalent to legally marketed predicate devices that were marketed in interstate commerce prior to May 28, 1976, or to devices that have been reclassified under the Federal Food, Drug, and Cosmetic Act. The device does not require premarket approval (PMA) as it meets the substantial equivalence standard for Class II surgical apparel.
View the full FDA submission: accessdata.fda.gov