Xiantao Sanda’s Surgical Face Mask Receives FDA 510(k) Clearance: What It Means

Xiantao Sanda Industrial Co., Ltd. received U.S. Food and Drug Administration 510(k) clearance for its Surgical Face Mask under 510(k) number K222651. The FDA issued its substantial-equivalence determination on December 13, 2022.

The FDA record identifies the device as a Surgical Face Mask under 21 CFR 878.4040. It is classified as a Class II medical device under product code FXX. The FDA-hosted 510(k) summary also identifies the device as meeting ASTM F2100-19 Level 3 performance criteria.

These details matter because “510(k) cleared,” “FDA registered,” and “FDA approved” do not mean the same thing. This article explains what the 510(k) pathway does, what the K222651 decision covers, and how the three performance levels in ASTM F2100-19 differ.

What Is an FDA 510(k)?

A 510(k) is a premarket notification submitted to the FDA for certain medical devices before they are marketed in the United States. Through this pathway, the submitter demonstrates that the proposed device is substantially equivalent to a legally marketed predicate device.

Substantial equivalence considers the device’s intended use and technological characteristics. If differences exist, the submission must provide information showing that those differences do not raise new questions of safety and effectiveness.

When the FDA reaches a substantial-equivalence determination, the device is described as “FDA cleared.” This is different from the Premarket Approval, or PMA, pathway used for many higher-risk Class III devices.

What Did the FDA Determine for Xiantao Sanda?

For K222651, the FDA reviewed the 510(k) premarket notification submitted for Xiantao Sanda’s Surgical Face Mask and determined that the device was substantially equivalent to legally marketed predicate devices for the stated indications for use.

The public FDA record lists:

• Applicant: Xiantao Sanda Industrial Co., Ltd.
• Trade/device name: Surgical Face Mask
• 510(k) number: K222651
• Regulation number: 21 CFR 878.4040
• Regulation name: Surgical apparel
• Regulatory class: Class II
• Product code: FXX
• Decision date: December 13, 2022

The clearance applies to the specific device described in the K222651 submission. It should not be interpreted as a blanket clearance for every mask, every protective product, or every future product variation made by the company.

General-Use Face Masks and 510(k)-Cleared Surgical Masks

Two disposable masks can look similar while having different intended uses, labeling, supporting data, and regulatory status. Appearance alone does not establish whether a mask is a medical device or whether it has received 510(k) clearance.

A general-use face covering may be intended for ordinary daily use. Unless a specific product is identified and supported by appropriate records, buyers should not assume that its design, testing, labeling, or regulatory status is the same as that of a cleared surgical mask.

A 510(k)-cleared surgical mask, by comparison, is an identified medical device tied to a specific FDA submission. Its public record connects the applicant, device name, product code, classification, decision, and supporting summary. Buyers can use the 510(k) number to verify that record in the FDA database.

The important distinction is therefore not simply how the mask looks. It is the combination of intended use, identified device, labeling, documented performance, and applicable regulatory pathway.

What Does ASTM F2100 Measure?

ASTM F2100 is a performance specification for materials used in medical face masks. The FDA-hosted K222651 summary cites the 2019 edition, so the comparisons below refer specifically to ASTM F2100-19.

The specification organizes medical face-mask material performance around several criteria:

• Bacterial filtration efficiency, or BFE
• Sub-micron particulate filtration efficiency, or PFE
• Differential pressure, or Delta-P
• Resistance to penetration by synthetic blood
• Flammability classification

BFE and PFE are laboratory measures of material filtration performance under specified test conditions. Differential pressure measures resistance to airflow through the mask material and is related to breathability. Synthetic-blood resistance evaluates fluid penetration resistance at a specified pressure. These test criteria should not be converted into a guarantee of protection for an individual wearer in every situation.

ASTM F2100-19 Level 1, Level 2, and Level 3

The following table summarizes the criteria stated in FDA-hosted 510(k) materials that apply ASTM F2100-19:

Level 1 has lower minimum BFE and PFE criteria than Levels 2 and 3. Levels 2 and 3 share the same minimum BFE and PFE values and the same maximum Delta-P criterion in ASTM F2100-19. Their clearest difference in this table is synthetic-blood resistance: Level 2 is evaluated at 120 mmHg, while Level 3 is evaluated at 160 mmHg.

This is why it is too simplistic to describe the three levels as three visibly different mask designs. The level is based on documented test criteria, not color, thickness, packaging style, or appearance.

What Level Is the Device in K222651?

The FDA-hosted 510(k) summary for K222651 identifies Xiantao Sanda’s Surgical Face Mask as ASTM F2100-19 Level 3.

The summary lists Level 3 criteria including:

• BFE of at least 98%
• PFE of at least 98%
• Differential pressure below 6.0 mmH2O/cm2
• Synthetic-blood resistance at 160 mmHg
• Flammability Class 1

This statement is specific to the surgical face mask described in K222651 and the documentation reviewed in that submission. It should not be extended to another model or product without checking the corresponding product identification and supporting records.

What 510(k) Clearance Does Not Mean

Accurate regulatory language is important. K222651 supports the statement that the identified Surgical Face Mask is FDA 510(k) cleared. It does not mean that:

• The FDA has “certified” the company or issued a general FDA certificate.
• Every product made by Xiantao Sanda is covered by K222651.
• A 510(k) clearance is the same as FDA approval through the PMA pathway.
• The clearance replaces establishment registration, device listing, labeling, quality-system, reporting, or other applicable obligations.
• Visual similarity to the cleared device proves that another mask has the same status or performance classification.

Buyers should verify the exact product, model information, labeling, current documentation, and target-market requirements for each purchasing project.

How Buyers Can Verify the Clearance

The 510(k) number provides a direct way to check the public FDA record. Buyers can search the FDA 510(k) database for K222651 and review the applicant name, device name, decision date, product code, clearance letter, and public 510(k) summary.

When reviewing a supplier’s regulatory documents, useful checks include:

• Does the company name match the FDA record?
• Does the device name match the product being discussed?
• Is the 510(k) number complete and searchable?
• Does the claimed ASTM level match the identified device and supporting summary?
• Are product labeling and purchasing documents consistent with the cleared device?
• Are current market-specific requirements being checked separately?

These steps help buyers distinguish a verifiable device-specific clearance from a broad or unsupported marketing statement.

A Device-Specific Regulatory Milestone

FDA 510(k) clearance K222651 is a device-specific regulatory milestone for Xiantao Sanda’s Surgical Face Mask. It establishes a public FDA record for the identified Class II device and documents the FDA’s substantial-equivalence determination.

For buyers, the value of the clearance lies in accurate product identification and verifiable documentation. For suppliers, it reinforces the importance of using precise regulatory language and connecting every claim to the correct device and supporting record.

To discuss the Surgical Face Mask covered by K222651 or request the corresponding product documentation, please contact Xiantao Sanda through the official website.