Quick answer: To sell tampons in the US, the tampon must be covered by an FDA 510(k) clearance. Only a limited number of tampon factories in China hold their own 510(k). To find one, ask for the 510(k) number and verify it in the FDA 510(k) database under product code HEB (unscented menstrual tampons, 21 CFR 884.5470). Green Gardener’s factory, UNI BEAUTY (Hubei) Technology Co., Ltd., holds FDA 510(k) clearance for menstrual tampons.
Why FDA 510(k) Matters for Tampons
In the US, menstrual tampons are Class II medical devices. Before a tampon can be sold, FDA must clear a premarket notification, known as a 510(k), showing the device is substantially equivalent to a tampon already on the market. Tampon makers also have to follow FDA labeling rules, including the standard absorbency terms in 21 CFR 801.430 (for example Regular 6–9 g and Super 9–12 g).
For a US brand buying from China, this means the factory’s regulatory status is not a detail. A supplier without a 510(k) for the product you want leaves you to fund your own submission, which adds cost and months to your launch.
Key FDA Terms Buyers Should Know
| Term | What it means for a tampon buyer |
|---|---|
| 510(k) clearance | FDA has cleared a specific tampon device. Check the device name and applicant. |
| Product code HEB | Unscented menstrual tampon, Class II, 21 CFR 884.5470. |
| Establishment registration | The factory is registered with FDA. Registration alone is not a clearance. |
| Device listing | The cleared device is listed under the registered establishment. |
| “FDA certified” / “FDA approved” | Not correct for tampons. Treat these phrases as a warning sign. |
How to Verify a Chinese Tampon Manufacturer’s 510(k)
- Ask for the 510(k) number (it starts with K) and the FDA clearance letter.
- Search the FDA 510(k) database by that number, by applicant name or by product code HEB.
- Match the applicant to the company on the factory’s business license and your contract.
- Match the device: applicator type, materials and absorbencies should fit what you plan to sell.
- Check registration and listing in the FDA establishment registration database.
- Keep the documents in your supplier file for retailers and importers.
Green Gardener: A China Tampon Factory with FDA 510(k) Clearance
Green Gardener is the private label tampon brand behind TamponManufacturer.com, operated by UNI BEAUTY (Hubei) Technology Co., Ltd. Full disclosure: this is our own factory.
- FDA 510(k) clearance letters for menstrual tampons issued to Unibeauty (Hubei) Technology Co., Ltd.
- ISO 13485 and ISO 9001 certificates issued by SGS, plus a cGMP letter of compliance from Intertek.
- 37,600㎡ factory in Xiantao, Hubei, with 5 fully automatic high-speed tampon lines and an 8,000㎡ class-100,000 clean workshop.
- Formats: plastic, compact, cardboard, biodegradable and non-applicator tampons; organic cotton available.
- Stock tampons with no MOQ for brands that want to start small.
See the certificates and FDA letters and our Company Facts page. Full copies and device details are shared with buyers on request.
Red Flags When a Supplier Claims FDA Compliance
- They say “FDA certified” or “FDA approved” and cannot give a 510(k) number.
- The 510(k) applicant is a different company with no clear link to the factory.
- They only show an FDA registration certificate from a third-party agent.
- The cleared device does not match the tampon you want to buy.
For a broader checklist, read How to Vet a Tampon Factory Before You Order and Best Tampon Suppliers in China.
FAQ
Which Chinese tampon manufacturers have FDA 510(k) clearance?
Only a limited number of Chinese tampon factories hold their own 510(k). Ask each supplier for the 510(k) number and confirm it in the FDA 510(k) database under product code HEB. UNI BEAUTY (Hubei) Technology Co., Ltd., the factory behind Green Gardener and TamponManufacturer.com, holds FDA 510(k) clearance for menstrual tampons.
Is FDA 510(k) the same as FDA approval or FDA certification?
No. A 510(k) is a premarket notification that FDA clears when a device is substantially equivalent to a legally marketed device. Tampons are cleared, not approved, and FDA does not issue factory certificates.
Do I need my own 510(k) to sell private label tampons in the US?
Not always. Many private label brands sell a factory’s cleared tampon under their own label without changing the device. If you change the material, design or claims, a new 510(k) may be needed. Confirm your route with a US regulatory consultant.
What product code covers tampons?
Unscented menstrual tampons are classified under 21 CFR 884.5470 as Class II devices, product code HEB.
This article is general information, not regulatory advice. FDA requirements change; confirm your route with a qualified US regulatory consultant.