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Private Labe/ Deodorant Maxipad

by Int'L Consumer Disposables

510(k) K830630

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK830630 Date18 Apr 1983ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
HHL
Device Class
Class II
Regulation
21 CFR Part 884.5425
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Private Label Deodorant Maxipad is a scented, deodorized menstrual pad designed for feminine hygiene. Classified as a Pad, Menstrual, Scented, it provides odor control during menstruation to enhance comfort and confidence.

This single-use, Class II medical device is supplied under FDA 510(k) clearance (K830630) and falls under regulation 884.5425. Intended for use in obstetrics/gynecology settings, it is packaged sterile and distributed in sizes corresponding to registration numbers listed in the FDA database. No reusable or MRI-compatible variants are indicated.

Other devices from Int'L Consumer Disposables

Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What sizes are available for the Private Label Deodorant Maxipad, and how do I identify them?

    The Private Label Deodorant Maxipad comes in multiple sizes, each corresponding to a unique FDA registration number. These include sizes like 3019469637, 3017907679, 3006710549, and others listed in the FDA database. The registration numbers are typically printed on the packaging or product itself, allowing you to match the size to your patient’s needs. Since they are single-use, each size is designed for different absorbency levels to accommodate varying menstrual flow.

  • Is the Private Label Deodorant Maxipad reusable, or is it meant for single-use only?

    The Private Label Deodorant Maxipad is explicitly designed for single-use only. This is a standard feature for menstrual pads to ensure hygiene and prevent cross-contamination. After use, the pad should be disposed of properly, and a new one should be used for continued odor control and comfort.

  • How is the Private Label Deodorant Maxipad packaged, and is it sterile?

    The Private Label Deodorant Maxipad is packaged sterile, which is a key feature for medical-grade menstrual products. This ensures that the pad is free from harmful bacteria or contaminants before use, reducing the risk of infection. The sterile packaging is standard for Class II medical devices like this one, particularly when used in clinical settings such as obstetrics or gynecology.

  • What makes this product different from regular deodorant pads found in non-medical stores?

    Unlike typical deodorant pads sold in non-medical retail settings, the Private Label Deodorant Maxipad is classified as a Class II medical device under FDA regulation 884.5425. It is specifically designed for use in obstetrics/gynecology settings and is packaged sterile, which distinguishes it from consumer-grade products. Additionally, its FDA 510(k) clearance (K830630) ensures it meets medical-grade standards for safety and efficacy, including odor control and comfort during menstruation.

  • Can the Private Label Deodorant Maxipad be used in an MRI environment, or are there any restrictions?

    The Private Label Deodorant Maxipad is not indicated for MRI-compatible use. Since it is a Class II medical device primarily intended for single-use in obstetrics/gynecology settings, there is no mention of MRI safety in its specifications or regulatory filings. Patients should avoid using it or any other non-MRI-compatible materials in an MRI environment to prevent interference or safety risks.