FDA.report

510(k) K231005

Device
Aurelia Surgical Mask ASTM Level 1; Aurelia Surgical Mask ASTM Level 2
Applicant
Supermax Healthcare Canada-Supermax Medical
510(k) number
K231005
Product code
FXX
Decision
Substantially Equivalent (SESE)
Decision date
2023-12-05
Date received
2023-04-07
Regulation
878.4040
Classification name
Mask, Surgical
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Nicolas Bergeron
Address
1001 Rue Jean-Talon Bureau 100 Saint-Bruno-De-Montarville CA J3V 0N3 J3V 0N3

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Other 510(k) Records For Product Code FXX

510(k)DeviceApplicantDecision date
K251967HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround VisorO&M Halyard, Inc.2026-03-18
K252534Surgical Face Mask (Ear mount)Zhejiang Hangkang Medical Equipment Co., Ltd.2026-03-03
K253398Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)Efofex, Inc.2026-02-19
K252830Disposable Surgical Face Mask (3P00B, C2900)Beatles Medical Supplies (Xiantao) Co., Ltd.2026-01-12
K252650Disposable Medical Face MaskMakrite Industries, Inc.2026-01-05
K243342KP Protective Face MaskKp Trading Co., Ltd.2025-12-22
K252941HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* EarloopsO&M Halyard, Inc.2025-12-11
K252964PRIMED Surgical and Procedure MasksPrimed Medical Products, Inc.2025-11-04
K251902Vitaform Procedural Mask - Blue (Vitaform Blue); Vitaform Procedural Mask with Shield (Vitaform-FS)Vitacore Industries, Inc.2025-09-17
K250082Procedure mask/Surgical mask/Face maskWinner Medical Co., Ltd.2025-06-18
K243010Fluidshield * 3 Fog-Free Surgical Mask with Wraparound Anti-Glare Visor (28804); Fluidshield * 3 Surgical Mask with SO SOFT* Lining (48208); Fluidshield * 3 Fog-Free Surgical Mask with SO SOFT* Lining (48207); Fluidshield * 3 Fog-Free Surgical Mask with SO SOFT* Lining, with Visor (48237); Fluidshield* 3 Fog-Free Surgical Mask with SO SOFT* Lining, Anti-Glare WrapAround Visor (48247); Fluidshield * 3 Fog-Free Procedure Mask with SO SOFT* Earloops (28797); Fluidshield * 3 Fog-Free ProceOwens & Minor (O&M) Halyard, Inc.2025-05-30
K242502Aurelia Surgical Mask ASTM Level-3 (2130)Supermax Healthcare Canada – Supermax Medical2024-11-12
K240916Surgical Face Mask (Tie on/ Ear loops)Xiantao Daoqi Plastic Co., Ltd.2024-10-18
K240286PRIMED Surgical Masks and PRIMED Procedure MasksPrimed Medical Products, Inc.2024-08-26
K233723Medical surgical maskGuangdong Kingfa Sci. & Tech.Co., Ltd.2024-07-29