Deluxe Sanitary Pad
FDA 510(k) K905178 · American Healthcare Corp.
510(k) numberK905178
Submission
- Device name
- Deluxe Sanitary Pad
- Applicant
- American Healthcare Corp.
Canada, CA - Received
- November 19, 1990
- Decision date
- March 4, 1991
- 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.
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| 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 |
|---|---|---|
| K043543 | Blood Glucose Monitoring SystemNBW · Traditional | 04/08/2005SE |
| K043512 | Easygluco IGM-0002 G2CGA · Traditional | 04/08/2005SE |
| K031501 | Easygluco, Model IGM0002NBW · Traditional | 10/16/2003SE |
| K924192 | I.V. Start Kit (AHC-50-54954KGX · Traditional | 08/27/1993SEKD |
| K923941 | Irrigation Tray W/ Bulb Syringe & Sterile SalineEYN · Traditional | 06/17/1993SEKD |
| K923940 | Irrigation Tray W/ Piston Syringe & Sterile SalineEYN · Traditional | 06/17/1993SEKD |
| K923939 | Irrigation Tray W/ Bulb Syringe & Sterile WaterEYN · Traditional | 06/17/1993SEKD |
| K923938 | Irrigation Tray W/ Piston Syringe & Sterile WaterEYN · Traditional | 06/17/1993SEKD |
| K924193 | Tracheostomy Care Set W/ Hydro PEROX(AHC-20-54685)BTO · Traditional | 06/16/1993SEKD |
| K924191 | Tracheostomy Care Set with Gloves and Extra TowelBTO · Traditional | 04/02/1993SESK |
Questions and answers
When was Deluxe Sanitary Pad cleared by the FDA?
Deluxe Sanitary Pad (K905178) received a 510(k) decision of Substantially Equivalent on March 4, 1991, 105 days after the submission was received.
What is the product code of K905178?
The FDA product code is HHD – Pad, Menstrual, Unscented, a Class I (low risk) device regulated under 21 CFR 884.5435.