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Surgical 3D Mask

by Inno Lifecare

510(k) K203565Ref D-0057.49, 8007TC, D-0051.45, N-0284.15, G-0300.02, D-0072.10, A-0112.52, D-0070.12, H-4025.01, G-0285.02, A-0056.07, G-0302.06, G-0404.01, G-0362.01, C-0031.03, A-0106.53, N-0283.17, A-0040.18, D-0055.49, N-0290.51, G-0284.06, C-0200.13, G-0404.02, A-0030.15, A-0030.60, A-0056.09, G-0300.04, A-0056.02, A-0030.05, G-0284.03, D-0057.44, A-0020.30, N-0280.01, D-0050.49, D-0071.12, D-0070.10, 8012TC, A-0100.03, C-0200.11, A-0112.58, 8010TC, A-0049.02, 8001TC, D-0064.49, A-0020.07, G-0300.03, A-0040.05, N-0290.42, D-0064.54, 8034TCModel C-0031.01, X-yyrr-ss, X-yyss-rr, A-0020.01

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K203565↗

FDA record

Trust

Unverified

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

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number6221274HoldingU6 Basic UDI-DI Date18 May 2026RegisteredStatusActive EUDAMED: not on the EU market
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK203565 Date19 Oct 2021ClearedStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

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

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

Trade Name
LifeCare
Device Name
Reusable Surgical Holding and Clamping
Reusable Surgical manipulating
Reusable Surgical Retractors
Reusable Surgical Cutting
Model / Reference
C-0031.01, D-0057.49, X-yyrr-ss, 8007TC, D-0051.45, N-0284.15, X-yyss-rr, G-0300.02, D-0072.10, A-0020.01, A-0112.52, D-0070.12, H-4025.01, G-0285.02, A-0056.07, G-0302.06, G-0404.01, G-0362.01, C-0031.03, A-0106.53, N-0283.17, A-0040.18, D-0055.49, N-0290.51, G-0284.06, C-0200.13, G-0404.02, A-0030.15, A-0030.60, A-0056.09, G-0300.04, A-0056.02, A-0030.05, G-0284.03, D-0057.44, A-0020.30, N-0280.01, D-0050.49, D-0071.12, D-0070.10, 8012TC, A-0100.03, C-0200.11, A-0112.58, 8010TC, A-0049.02, 8001TC, D-0064.49, A-0020.07, G-0300.03, A-0040.05, N-0290.42, D-0064.54, 8034TC
Primary DI / UDI-DI
06221274115410, 06221274188261, 06221274115298, 06221274174769, 06221274135531, 06221274115601, 06221274016106, 06221274115526, 06221274151647, 06221274135487, 06221274100355, 06221274135630, 06221274135753, 06221274135692, 06221274016380, 06221274100669, 06221274174752, 06221274100263, 06221274115335, 06221274174813, 06221274135470, 06221274111092, 06221274135760, 06221274100140, 06221274100188, 06221274100379, 06221274135555, 06221274100300, 06221274100126, 06221274135456, 06221274115397, 06221274100089, 06221274174707, 06221274115250, 06221274115564, 06221274115519, 06221274188308, 06221274100409, 06221274111085, 06221274016137, 06221274274926, 06221274100287, 06221274188209, 06221274115434, 06221274100027, 06221274135548, 06221274100232, 06221274174790, 06221274115441, 06221274188346
Basic UDI-DI
6221274HoldingU6, 6221274ManipulatingRG, 6221274RetractorsUB, 6221274Cutting2A
Direct Marketing DI
06221274115410
06221274188261
06221274115298
06221274174769
06221274135531
06221274115601
06221274016106
06221274115526
06221274151647
06221274135487
06221274100355
06221274135630
06221274135753
06221274135692
06221274016380
06221274100669
06221274174752
06221274100263
06221274115335
06221274174813
06221274135470
06221274111092
06221274135760
06221274100140
06221274100188
06221274100379
06221274135555
06221274100300
06221274100126
06221274135456
06221274115397
06221274100089
06221274174707
06221274115250
06221274115564
06221274115519
06221274188308
06221274100409
06221274111085
06221274016137
06221274274926
06221274100287
06221274188209
06221274115434
06221274100027
06221274135548
06221274100232
06221274174790
06221274115441
06221274188346
510(k) Number
FDA Product Code
FXX
EMDN Code
L031307, L091201, L149001, L03140104, L0102, L050901, L03140199, L031308, L010103, L03130499
Device Class
Class I EUDAMED
Class II 510(k)
Regulation
21 CFR Part 878.4040
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Truth per registry

2 sources · 1 field differs

FieldEUDAMED510(k)
Device ClassEUDAMED
Class I
510(k)
Class II

Overview

AI-generated summary, 18 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 Surgical 3D Mask is a face mask designed for surgical use, providing enhanced protection and filtration for healthcare professionals during procedures. Its three-dimensional structure ensures improved coverage and barrier integrity against airborne contaminants and splashes, supporting infection control in operating rooms and clinical settings.

This device is supplied as a single-use item, intended for one-time use per patient encounter. It is classified under the FDA’s 510(k) pathway as substantially equivalent to predicate devices, with regulatory compliance under the Medical Device Regulation (MDR). The mask is available in standard sizes and must be stored in a clean, dry environment to maintain sterility before use.

Questions

AI-generated answers, 18 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 types of clinical settings is the Surgical 3D Mask designed to protect against airborne contaminants and splashes in?

    The Surgical 3D Mask is specifically designed for use in operating rooms and clinical settings where infection control is critical. Its three-dimensional structure provides enhanced coverage and barrier integrity, making it suitable for surgical procedures where exposure to airborne contaminants and splashes is a concern.

  • Is the Surgical 3D Mask reusable, or is it intended for single-use only?

    The Surgical 3D Mask is explicitly intended for single-use only, meaning it is designed for one-time use per patient encounter. This ensures optimal hygiene and reduces the risk of cross-contamination between patients.

  • What storage conditions are required to maintain the sterility of the Surgical 3D Mask before use?

    To maintain sterility, the Surgical 3D Mask must be stored in a clean, dry environment. Proper storage conditions are essential to preserve its protective properties and ensure it remains safe for use in clinical settings.

  • What sizes are available for the Surgical 3D Mask, and how does this affect its fit for different users?

    The Surgical 3D Mask is available in standard sizes, which are designed to provide a secure and comfortable fit for healthcare professionals. The three-dimensional structure ensures improved coverage, but the exact sizing details should be verified against the manufacturer’s guidelines to ensure optimal protection and comfort.

  • How was the Surgical 3D Mask evaluated for regulatory compliance, and what pathway was followed?

    The Surgical 3D Mask was evaluated under the FDA’s 510(k) pathway, where it was determined to be substantially equivalent to predicate devices. This classification was confirmed through a traditional review process, with compliance also verified under the Medical Device Regulation (MDR). The device was reviewed by the Surgical and Urological Devices panel (SU) under the General, Plastic Surgery advisory committee category.

Properties

  • Reusable

Other properties (12)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No