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Novaplus 47597

by O&M Halyard Inc.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 ongoing

This device is named in the recall

Documents

510(k) K823078

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number20680651475972 UDI-DI Date16 May 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK823078 Date7 Jan 1983DecidedStatusActive

Recalls

2 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-0729-2025 FDA Class II initiated 8 Nov 2024
    • Ongoing Z-0728-2025 FDA Class II initiated 8 Nov 2024

    Not meeting the bioburden testing requirements of EN 14683 required for masks sold in Europe. Face masks sold in the United States are not required to meet this standard. However, if the standard is printed on the packaging, compliance is required.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Novaplus
Generic name
Surgical/medical face mask, non-antimicrobial, single-use
Model / Ref / Catalog
47597
Primary DI / UDI-DI
20680651475972
510(k) Number
FDA product code
FXX
GMDN term
Surgical/medical face mask, non-antimicrobial, single-use
Device class
Class II
Regulation number
878.4040
GUDID distribution status
In Commercial Distribution

Related devices

Category: Surgical/medical face mask, non-antimicrobial, single-use

Cleared under the same submission (K823078)

Show all (12)

Other devices from O&M Halyard Inc.

See all devices from O&M Halyard Inc. →

Properties

  • Single use
  • Lot / batch number
  • Expiration date

Other properties (12)

  • Supplied sterile: No
  • Sterilise before use: No
  • Implantable: No
  • Contains latex: No
  • Prescription use: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Manufacturing date: No