Browse hierarchy: [Obstetrics/Gynecology (OB)](/submissions/OB) → [Subpart F — Obstetrical and Gynecological Therapeutic Devices](/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices) → [21 CFR 884.5435](/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/884.5435) → PVT — Maternity Kit

# PVT · Maternity Kit

_Obstetrics/Gynecology · 21 CFR 884.5435 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/PVT

## Overview

- **Product Code:** PVT
- **Device Name:** Maternity Kit
- **Regulation:** [21 CFR 884.5435](/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/884.5435)
- **Device Class:** 1
- **Review Panel:** [Obstetrics/Gynecology](/submissions/OB)

## 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._

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**Source:** [https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/PVT](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/PVT)

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