PVT · Maternity Kit
Obstetrics/Gynecology · 21 CFR 884.5435 · Class 1
Overview
| Product Code | PVT |
|---|---|
| Device Name | Maternity Kit |
| Regulation | 21 CFR 884.5435 |
| Device Class | Class 1 |
| Review Panel | Obstetrics/Gynecology |
Identification
An unscented menstrual pad is a device that is a pad made of cellulosic or synthetic material which is used to absorb menstrual or other vaginal discharge. This generic type of device includes sterile unscented menstrual pads used for medically indicated conditions, but does not include menstrual pads treated with scent (i.e., fragrance materials) or those with added antimicrobial agents or other drugs.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9 only when the device is made of common cellulosic and synthetic material with an established safety profile.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
