Sourcing Face Masks From China: N95, Surgical and Everyday Masks
Quick answer: In the US, a mask's label decides which rules it follows. A surgical or medical mask is a Class II medical device and needs FDA 510(k) clearance. An N95 is a respirator approved by NIOSH, and it must appear on NIOSH's Certified Equipment List under the exact manufacturer and model. KN95 is a Chinese standard; a KN95 isn't NIOSH-approved and can't be sold as an N95. Everyday masks sold with no medical or infection-control claims aren't medical devices at all. So the safest route from China is a factory that already holds the clearance or approval for the exact model, verified by you in the public databases. PackQuay can source and check those masks, but we don't arrange FDA clearance or NIOSH approval.
Four kinds of mask, four sets of rules
| Type | Who regulates it | What must exist before you sell | What you may claim |
|---|---|---|---|
| Surgical / medical mask | FDA, Class II medical device (surgical apparel, product code FXX) | 510(k) clearance for that model; factory registered with the FDA and the device listed, with a US agent | Only the intended use in its clearance. Say "FDA cleared," never "FDA approved" |
| N95 respirator | NIOSH, under 42 CFR Part 84 | NIOSH approval; manufacturer and model on the Certified Equipment List; approval number (TC-84A-xxxx) and the NIOSH markings on the mask | "NIOSH-approved N95," only for the listed model |
| Surgical N95 | NIOSH and FDA together | NIOSH approval as a surgical N95 (most no longer need a separate 510(k) since a 2018 FDA–NIOSH arrangement); some claims still need FDA review | Only what the approval covers |
| KN95 / KF94 | Chinese / Korean standards; not NIOSH-approved | Nothing that makes it an N95. Sold for medical use, it would need FDA authorization like any medical mask | Its own standard. Never "N95" or "NIOSH" |
| Everyday / fashion mask | Not a medical device when no medical purpose is claimed | Normal consumer product rules; a children's version is a children's product | Comfort, style, dust. No germ, virus or disease claims |
A barrier face covering tested to the ASTM F3502 standard is a middle option: the standard defines design, filtration levels and labeling, and conformity is shown with a supplier's declaration backed by an accredited lab. The standard itself says such a covering is neither a medical face mask nor a respirator, so it doesn't let you make medical claims.
What changed after the pandemic
During COVID-19, the FDA relaxed enforcement on several kinds of masks. That's over for most of them. Its enforcement policy for surgical masks, face shields and respirators ended on November 7, 2023, and since then surgical masks need 510(k) clearance again. A separate policy for face masks and barrier face coverings was tied to an HHS emergency declaration that HHS has terminated with effect from December 26, 2026. Don't build a mask range on pandemic-era flexibility, and be wary of suppliers whose paperwork dates from 2020 and relies on it.
How to spot a fake N95
Counterfeit respirators, sold as NIOSH-approved when they aren't, are a documented problem, and NIOSH keeps a public list of them. Warning signs from NIOSH's guidance:
- No NIOSH marking on the respirator, or "NIOSH" spelled wrong.
- No approval number (TC-84A-xxxx) on the respirator or headband.
- Decorative fabric or add-ons such as sequins.
- Claims that it's approved for children. NIOSH doesn't approve respirators for children.
- "FDA approved" as the main selling claim.
A real TC number isn't enough on its own. NIOSH has found counterfeits printed with a genuine, active approval number that belongs to another manufacturer's model. Look the number up on the Certified Equipment List and check that the approval holder and model match your supplier and your sample exactly.
Before you order: a checklist
- Decide the claim first. Medical, respirator or everyday. Everything else follows from it, including your product photos and ad captions.
- For surgical masks: get the 510(k) number from the factory and find it in the FDA's 510(k) database. Check the company name, the model and the intended use. Then check the factory's registration and device listing.
- For N95s: get the TC approval number and model, find them on the Certified Equipment List, and confirm the approval holder. If the factory makes the mask for an approval holder, ask how that link is documented.
- Compare the sample with the paperwork: markings, model name, box labeling, lot numbers.
- Check the listing copy: remove "kills viruses," "prevents COVID" and similar claims unless the clearance covers them.
- Children's masks: an everyday mask made for children 12 and under is a children's product in the US, with testing and certificate requirements. Never sell a child-size mask as an N95.
- Talk to your customs broker about how the entry will be filed. Medical devices have their own entry data.
- Keep the documents for every batch you buy.
Who is responsible
- The manufacturer holds the 510(k) clearance or NIOSH approval and its FDA registration and listing, and names a US agent.
- You, as the seller or importer, are responsible for what your listings claim and for importing correctly. Selling a fake N95 is your problem, not just the factory's.
- Your customs broker files the entry.
- PackQuay finds factories that already hold clearance or approval for the model you want, collects their documents, and checks at inspection that markings, model names and lot numbers match. We don't file 510(k)s, apply for NIOSH approval or act as anyone's US agent, and we can't certify a mask for you.
Is a mask store still worth it?
Demand for masks is steadier and lower than in 2020–2021, and the regulated end of the market is crowded with big brands. Small stores tend to do better with clearly non-medical products, such as comfortable everyday masks, dust masks for DIY and gardening, and mask accessories, or by selling cleared and approved models from verified factories with honest listings. A mask brand with your own logo is possible for everyday masks; for medical masks or N95s, the clearance or approval belongs to the factory and its model, so private-label versions need careful regulatory advice first.
For more on vetting a factory before you commit, see our sourcing agent guide, and for other FDA- and EPA-regulated health products, our guide to health and hygiene products.
How PackQuay helps
PackQuay sources from factories in China and checks every batch in our own warehouse in Xinxiang, Henan.
- Sourcing and documents: factory search, quotes and the paperwork each factory can show. See product sourcing.
- Inspection: 20% of each batch free; full marking and lot checks at $7 per hour per person. See product inspection.
- Packaging: your own boxes or mailers for everyday masks. See packaging and branding.
Message us on WhatsApp with the mask type you want to sell, and we'll come back with factories and the documents they hold.
FAQ
Do surgical masks need FDA clearance to sell in the US?
Yes. Surgical and medical masks are Class II medical devices that need 510(k) clearance, and the factory must be registered with the FDA and the device listed. The pandemic-era enforcement policy for surgical masks ended on November 7, 2023.
Is a KN95 the same as an N95?
No. KN95 is a Chinese standard and KN95 masks are not NIOSH-approved, so they can't be sold or labeled as N95s in the US. Only respirators approved by NIOSH and listed on its Certified Equipment List are N95s.
How do I check that an N95 is genuine?
Look for NIOSH markings and a TC-84A approval number on the respirator, then find that number on NIOSH's Certified Equipment List and confirm the approval holder and model match your supplier and sample. Counterfeits sometimes carry a real number that belongs to another manufacturer.
Can I sell everyday cloth or fashion masks without FDA approval?
Yes, if you make no medical claims. Masks sold for non-medical purposes aren't medical devices. Claims about preventing disease or filtering viruses would bring FDA rules into play.
Can PackQuay get FDA clearance or NIOSH approval for my masks?
No. We source from factories that already hold clearance or approval for the model, collect their documents and check markings during inspection. Clearances and approvals stay with the manufacturer.