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PRECISION ECO Compostable / Plant Based Procedural Mask with Earloops

by Padm Medical, Inc.

510(k) K221209

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 NumberK221209 Date8 Mar 2023ClearedStatusActive

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  • Withdrawn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
FXX
Device Class
Class II
Regulation
21 CFR Part 878.4040
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

This device is a Protective Face Mask (Device Type: FXX) designed to provide barrier protection against microorganisms, body fluids, and particulate matter during medical procedures. Constructed from compostable, plant-based materials, it is intended for single-use in clinical settings to reduce exposure risks for both patients and healthcare providers. The four-layer construction meets ASTM Level 3 filtration standards, ensuring enhanced respiratory protection.

The mask is supplied non-sterile and is intended for single-use only. It is manufactured by Padm Medical, Inc. and holds an FDA 510(k) clearance (K221209) under the General, Plastic Surgery advisory committee. No MRI safety classification or reusable processing instructions are specified. Proper disposal follows compostable material guidelines, and storage should maintain dry conditions to preserve integrity.

Questions

AI-generated answers, 1 Oct 2026

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

  • What is the Precision ECO Compostable Mask designed for?

    This mask is designed to provide barrier protection against microorganisms, body fluids, and particulate matter during medical procedures. Its four-layer construction meets ASTM Level 3 filtration standards, offering enhanced respiratory protection for both patients and healthcare providers in clinical settings.

  • Is the Precision ECO Compostable Mask sterile?

    No, the mask is supplied in a non-sterile state. It is intended for single-use only, so sterility is not required for its intended purpose. Always follow standard infection control protocols when handling non-sterile medical devices.

  • Can the Precision ECO Compostable Mask be reused?

    No, this mask is explicitly designed for single-use only. Reusing it could compromise its protective integrity and increase exposure risks to both users and patients. Proper disposal after one use is recommended.

  • How should the Precision ECO Compostable Mask be stored?

    Storage should be done in a dry environment to maintain the mask’s structural integrity and prevent degradation. Avoid exposure to moisture, heat, or direct sunlight, as these conditions can compromise the material’s compostability and performance.

  • How should the Precision ECO Compostable Mask be disposed of?

    Since the mask is made from compostable, plant-based materials, disposal should follow local composting guidelines. Check with your facility’s waste management protocols to ensure proper handling and compliance with environmental regulations.