"FDA cleared" and "FDA approved" are often used as if they meant the same thing. They do not. For surgical masks and surgical gowns, the one that counts is FDA 510(k) clearance, and you can check it yourself in a few minutes. This guide explains what a 510(k) is, what it covers and what it does not, and how to verify a supplier's claim before you buy.
What a 510(k) is
A 510(k) is a premarket notification filed with the FDA before a medical device can be sold in the US. The manufacturer shows that its device is substantially equivalent to a device already legally on the market, called the predicate. It does so by comparing intended use, materials and technology, and by submitting performance and safety test data.
If FDA agrees, it sends a letter stating that the device is substantially equivalent and may be marketed, subject to FDA's general controls. Each clearance gets a unique number starting with K, such as K202845.
Cleared vs approved
FDA clears devices through the 510(k) process. FDA approves devices through premarket approval (PMA), a separate and more demanding pathway used for most high-risk Class III devices. Surgical masks and gowns are not PMA devices, so "FDA approved" is the wrong term for them. The clearance letters themselves refer to 21 CFR 807.97, "Misbranding by reference to premarket notification": a 510(k) clearance should not be presented as an official FDA approval. That is why we write "FDA 510(k) cleared".
Establishment registration and device listing are a different matter again. They are separate obligations, not a product review, and they say nothing about whether a specific mask or gown performs as claimed.
Common wording, decoded
| Claim you may see | What it actually tells you |
|---|---|
| "FDA approved" mask or gown | Wrong term. Surgical masks and gowns are cleared through a 510(k), not approved |
| Claims based on "registration" | Establishment registration is not a review of the product |
| "FDA cleared", no K number | You cannot verify it. Ask for the number |
| "Meets FDA standards" | Vague. Ask which standard (ASTM F2100, AAMI PB70) and which level |
| "FDA 510(k) cleared, K______" | You can verify it. Look the number up and match the device name |
Which masks and gowns need a 510(k)
Surgical masks and surgical gowns are regulated under 21 CFR 878.4040 (surgical apparel) as Class II devices and need a 510(k):
| Product | FDA class | 510(k) required? | FDA product code |
|---|---|---|---|
| Surgical mask | Class II | Yes | FXX |
| Surgical gown | Class II | Yes | FYA |
| Surgical isolation gown | Class II | Yes | - |
| Non-surgical gown (low/minimal-risk isolation) | Class I | No (exempt from premarket review) | - |
Products such as industrial coveralls are not surgical apparel, and the 510(k) question does not apply to them in the same way. If a supplier calls a coverall "FDA cleared", ask for the K number and check it.
What FDA looks at for masks and gowns
A 510(k) summary, which FDA publishes, lists the tests behind the clearance. For our products these were:
Surgical mask, ASTM F2100 Level 3 (Myflon, K212111):
- fluid resistance to synthetic blood, ASTM F1862 (passed at 160 mmHg);
- bacterial filtration efficiency, ASTM F2101 (>= 98%) and particle filtration efficiency, ASTM F2299 (>= 98%);
- differential pressure (breathability) and 16 CFR 1610 flammability (Class 1);
- biocompatibility: cytotoxicity, irritation and sensitization (ISO 10993-5 and -10).
Surgical gowns, AAMI PB70 (Bodygard SFS Level 3, K202845; Level 4, K221139):
- liquid barrier per AAMI PB70: AATCC 42 and AATCC 127 for Level 3, plus ASTM F1671 viral penetration for Level 4, and ASTM F1670 synthetic blood for both;
- breaking, tear and seam strength, linting, water-vapor transmission and flammability;
- ISO 10993 biocompatibility and ethylene oxide residuals;
- sterile packaging: shipping, seal strength, leak and accelerated-aging tests.
The summaries state that no clinical tests were performed. These clearances rest on bench, biocompatibility and packaging testing.
What a 510(k) clearance does not mean
The FDA clearance letter says it plainly: a substantial-equivalence decision does not mean FDA has determined that the device complies with all other requirements of the law. The manufacturer still has to meet registration and listing, labeling, quality-system and adverse-event reporting rules. Clearance is also tied to one device and its stated indications. It does not carry over to a supplier's other products, to a re-branded copy, or to a different level of the same product line.
How to verify a K number in five steps
- Get the K number from the product label, spec sheet or product page. If the supplier will not give one, treat "FDA cleared" as unproven.
- Search the FDA 510(k) database (accessdata.fda.gov, Premarket Notification 510(k)) for that number.
- Match the record to the product. Check the device name (for example, "Bodygard SFS Surgical Gown Level 4"), the applicant (the 510(k) holder, often the manufacturer), the product code (FXX for masks, FYA for surgical gowns) and the decision date.
- Open the 510(k) summary and compare the indications, level (ASTM F2100 or AAMI PB70), sizes and sterility with what you are buying.
- Check the label of the delivered product against the same details.
Bodygard and Myflon 510(k) clearances
| Device (trade name) | 510(k) | Product code | Decision date | Summary |
|---|---|---|---|---|
| Myflon Surgical Mask Level 3 | K212111 | FXX | January 23, 2022 | |
| Bodygard SFS Surgical Gown Level 3 | K202845 | FYA | February 24, 2022 | |
| Bodygard SFS Surgical Gown Level 4 | K221139 | FYA | November 10, 2022 |
Bodyguard Advanced Materials LLC of Miami, FL supplies these products in the US. Our other products (FLX disposable coveralls, scrub suits, drape packs and OR towels) are not covered by these clearances, and we do not describe them as FDA cleared.
Questions to ask any mask or gown supplier
- What is the K number, and does the device name in the FDA record match this exact product?
- Which ASTM F2100 level (masks) or AAMI PB70 level (gowns) is on the label?
- Who is the 510(k) holder, and what is your relationship to them?
- Is the gown sterile? By what method, and to what SAL?
- Can you send the 510(k) summary, a spec sheet and samples?
Next steps
See the spec tables on the Myflon Level 3 mask, Bodygard SFS Level 3 gown and Bodygard SFS Level 4 gown pages. If you are choosing between gown levels, read Level 3 vs Level 4 Surgical Gowns. For bulk pricing or samples, email sales@bodyguardus.com or call +1 (201) 881-2055.
22 October 2026
