Kotex Lightdays Longs Deodorant & Reg. Pantiliners
FDA 510(k) K882364 · Kimberly-Clark Corp.
510(k) numberK882364
Submission
- Device name
- Kotex Lightdays Longs Deodorant & Reg. Pantiliners
- Applicant
- Kimberly-Clark Corp.
Washington, DC, US - Received
- June 8, 1988
- Decision date
- August 2, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HHD – Pad, Menstrual, Unscented
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 884.5435
- Specialty
- Obstetrics/Gynecology
An unscented menstrual pad which is used to absorb menstrual fluid or other vaginal discharge and is made of common cellulosic and synthetic material with an established safety profile.
Other 510(k)s with product code HHD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K071827 | Always Menstrual PadsHHD · Traditional | Procter & Gamble, Inc. | 09/20/2007SE |
| K012629 | Always DuetsHHD · Traditional | Procter & Gamble Co. | 10/05/2001SE |
| K003843 | Envive MiniformsHHD · Traditional | Procter & Gamble Co. | 02/08/2001SE |
| K993870 | Unscented Interlabial Menstrual PadHHD · Traditional | Procter & Gamble Co. | 01/18/2000SE |
| K980395 | Gladrags Cotton Menstrual PadHHD · Traditional | Keepers!, Inc. | 04/16/1998SE |
| K953470 | Flushies Flushable/Biodegradable Menstrual Pads/Napkins (Ultra Thins)HHD · Traditional | Mediquip, Inc. | 11/21/1995SE |
| K953668 | Unscented Ultrathin Maxi PadHHD · Traditional | Paragon Trade Brands, Inc. | 11/01/1995SE |
| K953667 | Unscented Curved Ultrathin Maxi PadsHHD · Traditional | Paragon Trade Brands, Inc. | 11/01/1995SE |
| K953633 | Unscented Menstrual PadHHD · Traditional | Tendasoft, Inc. | 11/01/1995SE |
| K953553 | Unscented Menstral PadHHD · Traditional | Paragon Trade Brands, Inc. | 10/27/1995SE |
More from Paragon Trade Brands, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K231435 | KIMTECH Polaris Xtra Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy…LZA · Traditional | 08/28/2023SE |
| K231021 | KIMTECH Polaris Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy…LZA · Traditional | 07/21/2023SE |
| K223749 | U by Kotex® Click® Unscented Menstrual TamponsHEB · Traditional | 01/06/2023SE |
| K202416 | Kimtech Prizm Multi-Layered Exam Glove Tested for use with Chemotherapy Drugs, the…LZA · Traditional | 11/30/2020SE |
| K200072 | KIMTECH Purple Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy…LZA · Traditional | 04/10/2020SE |
| K172118 | U by Kotex Click Unscented Menstrual TamponsHEB · Traditional | 10/11/2017SE |
| K143164 | ON-Q Pain Relief System, QuikBloc Over-the-Needle Catheter SetBSO · Special | 12/02/2014SE |
| K140963 | Kimguard Smart-Fold Sterilization WrapFRG · Traditional | 11/10/2014SE |
| K141294 | U by Kotex Security Unscented Menstrual TamponsHEB · Traditional | 08/25/2014SE |
| K140539 | Aero Blue Performance Surgical GownFYA · Abbreviated | 06/09/2014SE |
Questions and answers
When was Kotex Lightdays Longs Deodorant & Reg. Pantiliners cleared by the FDA?
Kotex Lightdays Longs Deodorant & Reg. Pantiliners (K882364) received a 510(k) decision of Substantially Equivalent on August 2, 1988, 55 days after the submission was received.
What is the product code of K882364?
The FDA product code is HHD – Pad, Menstrual, Unscented, a Class I (low risk) device regulated under 21 CFR 884.5435.