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Surgical Face Masks (Ear Loops and Tie-On)

by San-M Package Co., Ltd. 2 variants

510(k) K221534

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 NumberK221534 Date16 Sep 2022ClearedStatusActive

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  • Withdrawn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 surgical face mask classified under the FDA Product Code FXX for infection control. It is designed as a four-layer, flat-folded mask constructed from nonwoven polypropylene, featuring ear loops made of polyester and polyurethane or adjustable ties of polypropylene/polyester. The mask includes a malleable nosepiece for improved fit and comfort, ensuring a secure seal during use in clinical settings.

The masks are intended for single-use by healthcare personnel and patients to reduce the risk of airborne and droplet transmission. Supplied in sterile packaging, they comply with FDA 510(k) clearance (K221534) under a traditional review pathway. No MRI safety or reusable specifications are indicated; storage should follow manufacturer guidelines for sterile barrier integrity. The device is regulated under the General, Plastic Surgery advisory committee classification.

Other devices from San-M Package Co., Ltd.

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 primary purpose of these surgical face masks?

    These masks are designed to reduce the risk of airborne and droplet transmission in healthcare settings. The four-layer construction, including a malleable nosepiece, helps create a secure seal around the face, ensuring better protection for both healthcare personnel and patients during procedures.

  • Are these masks single-use or reusable?

    These masks are intended for single-use only. The sterile packaging ensures they remain uncontaminated until first use, and reuse is not recommended as it could compromise their effectiveness and sterility.

  • What materials are used in the construction of these masks?

    The masks are made from nonwoven polypropylene for the main layers, with ear loops constructed from polyester and polyurethane or adjustable ties made of polypropylene/polyester. These materials provide durability, breathability, and a secure fit.

  • How should these masks be stored to maintain sterility?

    Storage should follow the manufacturer’s guidelines to preserve the sterile barrier integrity of the packaging. Avoid exposing the masks to moisture, extreme temperatures, or physical damage, as these can compromise their sterility and performance.

  • What regulatory clearance does this device hold?

    This device holds FDA 510(k) clearance under the product code FXX, with the clearance number K221534. It was reviewed through the traditional pathway and classified under the General, Plastic Surgery advisory committee.