Femtex
Multi Pack 8 Light, 20 Regular, 8 Super Plastic Applicator Tampons
10manufacturers in China registered for this device type
17catalogue numbers in this listing
8510(k) clearances naming this product code
1recall
Who Else Makes It
Concentrated in Guangdong (2), Fujian (2), Shandong (2).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Foshan Niceday Sanitary Products Co., Ltd. | Foshan | Guangdong | Contract manufacturer | 19 |
| Fujian Time AND Tianhe Industrial Co., Ltd. | Nanan | Fujian | Contract manufacturer | 9 |
| Guangdong Bingbing Health Care Products Ltd. | Jiangmen | Guangdong | Repacker / relabeller | 7 |
| Fujian Tonggang Industries Ltd. | Quanzhou | Fujian | Manufacturer | 6 |
| Shandong Intco Hygiene Products Co., Ltd. | Zibo | Shandong | Contract manufacturer | 2 |
| Eisungrain (Shandong) Eco Technology Co., Ltd. | Zibo | Shandong | Exporter | 2 |
| Unibeauty (Hubei) Technology Co., Ltd. | Xiantao | Hubei | Manufacturer | 1 |
| Suzhou Borage Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 1 |
| Zhejiang Tianqing Manufacturing Technology Group Co., Ltd. | Huzhou | Zhejiang | Specification developer | 1 |
| Hangzhou Pengtu Chemical Fiber Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 1 |
Record
| Listed by | First Quality Hygienic, Inc., United States |
|---|---|
| FDA product code | HEB |
| Device type | Tampon, Menstrual, Unscented |
| Device class | Class 2 |
| Regulation | 21 CFR 884.5470 |
| Record published | 2016-08-16 |
| Record revised | 2022-06-10 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, manufacturing date |
| Packaging | Shipping container of 4, shipping container of 12, case of 4, case of 24 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| FT64003FN | 40 | In distribution | |
| FT11804UA/FT11812UO | 18 | In distribution | |
| FT30824F/1 | 8 | In distribution | |
| FT24012FN/1 | 8 | In distribution | |
| FT34012FN/1 | 40 | In distribution | |
| FT13606UO | 36 | In distribution | |
| FT20824F/1 | 8 | In distribution | |
| FT20624UA | 6 | In distribution | |
| FT31804UA | 18 | In distribution | |
| FT10824F/1 | 8 | In distribution | |
| FT21812UO/2 | 18 | In distribution | |
| FT22004F | 20 | In distribution | |
| FT62603UA | 32 | In distribution | |
| FT12004F | 20 | In distribution | |
| FT14012FN/1 | 12 | In distribution | |
| FT32004F | 20 | In distribution | |
| FT10624UA | 6 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Tampax | Procter & Gamble Manufacturing Company, THE | 509 |
| U By Kotex | Kimberly-Clark Global Sales, Inc. | 185 |
| Playtex | Edgewell Personal Care Brands, LLC | 71 |
| Cora | Cora | 66 |
| CVS Health Tampons | Woonsocket Prescription Center, Incorporated | 61 |
| This is L | Procter & Gamble Manufacturing Company, THE | 46 |
| Walgreens | Walgreen Co. | 38 |
| Daye | Tampon Innovations Ltd OOD | 34 |
| H-E-B Tampons | H. E. Butt Grocery Company | 32 |
| Rite Aid Tampons | AL-BAD Massuot Yitzhak Ltd | 28 |
| DG Health Tampons | Dolgencorp, LLC | 23 |
| Kroger Tampons | Kroger Co., THE | 22 |
Showing 12 of 161. All products under Tampon, Menstrual, Unscented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K161877 | 2016-08-05 |
| K151470 | 2015-11-02 |
| K050660 | 2005-05-12 |
| K031067 | 2003-07-14 |
| K023479 | 2002-11-26 |
| K963034 | 1996-11-01 |
| K963032 | 1996-10-11 |
| K920238 | 1993-08-02 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2010-03-25 | Not classified | Labeling mix-ups | Life Brand Regular Absorbency 40 Count Unscented Plastic Applicator Tampons package contained Super Plus Unscented Plastic Applicator Tampons. | 195 Cases/2340 Cartons | 2010-10-06 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.