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PointCore Surgical Mask

by Pointcore, Inc.

510(k) K220944

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 NumberK220944 Date9 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  • Withdrawn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, 24 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 PointCore Surgical Mask is a single-use, non-sterile, 3-ply flat-pleated surgical mask. It features an outer polyethylene/polyester layer, a meltblown nonwoven filter layer, and an inner polypropylene layer. The mask includes an adjustable nose piece and elastic ear loops for securing to the user's face.

The PointCore Surgical Mask is supplied in a finished size of 175mm x and has an ASTM Level 2 rating. It is authorized under FDA 510(k) clearance K220944 and is intended for use as a surgical mask. The device is designed for single-use and is not sterile.

Questions

AI-generated answers, 24 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 is the PointCore Surgical Mask used for?

    The PointCore Surgical Mask is intended for use as a surgical mask, providing a barrier to protect the user and others from potential contaminants.

  • Is the PointCore Surgical Mask sterile?

    No, the PointCore Surgical Mask is non-sterile, but it features a 3-ply design with a meltblown nonwoven filter layer to help filter out particles.

  • How is the PointCore Surgical Mask supplied?

    The PointCore Surgical Mask is supplied in a finished size of 175mm and is designed for single-use, with an adjustable nose piece and elastic ear loops for securing to the user's face.

  • What is the ASTM rating of the PointCore Surgical Mask?

    The PointCore Surgical Mask has an ASTM Level 2 rating, indicating its level of fluid resistance and filtration efficiency.