Rael Organic Cotton Tampons: Regular Absorbancy
A traditional unscented menstrual 100% organic cotton tampon consisting of an absorbent pledget, a withdrawal cord, and an applicator. The pledget is of the traditional cylindrical,…
A traditional unscented menstrual 100% organic cotton tampon consisting of an absorbent pledget, a withdrawal cord, and an applicator. The pledget is of the traditional cylindrical, bullet-like shape and the applicator has a standard rounded tip to ease insertion. Each tampon is individually wrapped and packaged in multi-unit containers for retail sale. It will be offered in two absorbencies: Regular and Super.
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 | Rael, Inc., United States |
|---|---|
| FDA product code | HEB |
| Device type | Tampon, Menstrual, Unscented |
| Device class | Class 2 |
| Regulation | 21 CFR 884.5470 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K182814 |
| Record published | 2019-08-20 |
| Record revised | 2022-06-10 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| RAEL-TP-RG-01 | 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 |
|---|---|
| K182814 | 2019-07-15 |
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.