Dong Hai Xiang Surgical Mask
by Taizhou Donghaixiang Protective Equipment Co., Ltd.
510(k) K212203
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK212203 | Date7 Apr 2022 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- FXX
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4040
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Dong Hai Xiang Surgical Mask is a disposable surgical mask classified under 21 CFR 878.4040 as surgical apparel. It is designed to provide a barrier against liquid contamination, airborne particles, and splashes, ensuring protection for both healthcare providers and patients during surgical and medical procedures. Constructed from non-woven materials, it adheres to standards for fluid resistance and filtration efficiency, meeting regulatory requirements for Class II devices.
This mask is intended for single-use in clinical settings, including operating rooms, dental offices, and other sterile environments. Supplied in sterile packaging, it must be stored in a clean, dry area away from direct sunlight or extreme temperatures. The device holds FDA 510(k) clearance (K212203) under the Traditional review pathway, with a decision date of April 7, 2022, and is classified under the General, Plastic Surgery advisory committee category. Compliance with 21 CFR 878.4040 ensures its suitability for surgical applications.
Other devices from Taizhou Donghaixiang Protective Equipment Co., Ltd.
Questions
AI-generated answers, 19 Sep 2026
What types of clinical settings is this mask intended for, and how does its design support those environments?
The Dong Hai Xiang Surgical Mask is designed for single-use in sterile environments like operating rooms, dental offices, and other medical procedures where protection from liquid contamination, airborne particles, and splashes is critical. Its construction from non-woven materials ensures fluid resistance and filtration efficiency, meeting regulatory standards for surgical apparel under 21 CFR 878.4040. This makes it suitable for healthcare providers and patients during surgical and medical procedures where maintaining sterility is essential.
Is this mask reusable, and if not, how should it be disposed of after use?
This mask is explicitly designed for single-use only, as indicated in the device description. Since it is disposable, it should be discarded immediately after use in accordance with standard medical waste protocols to prevent contamination and ensure infection control. The sterile packaging ensures it remains uncontaminated until first use.
What storage conditions are required to maintain the mask’s sterility and performance?
The mask must be stored in sterile packaging and kept in a clean, dry area away from direct sunlight or extreme temperatures. Exposure to moisture, heat, or cold could compromise its fluid resistance and filtration efficiency, so adherence to these conditions is critical for maintaining its intended performance as a Class II surgical device.
How do I verify the regulatory compliance of this mask before purchasing?
This mask holds FDA 510(k) clearance (K212203) under the Traditional review pathway, with a decision date of April 7, 2022. It is classified under product code FXX and adheres to 21 CFR 878.4040 for surgical apparel. To verify compliance, check the FDA’s device database using the K-number (K212203) or confirm the manufacturer’s documentation includes this clearance information.