FDA 510(k)

Dukal Corporation Level 3 Surgical Face Masks with Ear loop, Dukal Corporation Level 3 Surgical Face Masks with Tie On

K-Number: K201732 · 2021-02-16

Decision Date2021-02-16

Product CodeFXX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Dukal Corporation Level 3 Surgical Face Masks with Ear loop, Dukal Corporation Level 3 Surgical Face Masks with Tie On is the device name listed in this FDA 510(k) record. The listed applicant is Dukal Corporation. It received FDA 510(k) clearance on 2021-02-16 under 510(k) number K201732. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Dukal Corporation Level 3 Surgical Face Masks with Ear loop, Dukal Corporation Level 3 Surgical Face Masks with Tie On?

Dukal Corporation Level 3 Surgical Face Masks with Ear loop, Dukal Corporation Level 3 Surgical Face Masks with Tie On is a medical device that received FDA 510(k) clearance on 2021-02-16. The listed applicant is Dukal Corporation. The 510(k) number is K201732.

When did Dukal Corporation Level 3 Surgical Face Masks with Ear loop, Dukal Corporation Level 3 Surgical Face Masks with Tie On receive FDA 510(k) clearance?

Dukal Corporation Level 3 Surgical Face Masks with Ear loop, Dukal Corporation Level 3 Surgical Face Masks with Tie On received FDA 510(k) clearance on 2021-02-16, under 510(k) number K201732.

Who is the listed applicant for Dukal Corporation Level 3 Surgical Face Masks with Ear loop, Dukal Corporation Level 3 Surgical Face Masks with Tie On?

The FDA 510(k) record lists Dukal Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dukal Corporation Level 3 Surgical Face Masks with Ear loop, Dukal Corporation Level 3 Surgical Face Masks with Tie On?

The FDA product code for Dukal Corporation Level 3 Surgical Face Masks with Ear loop, Dukal Corporation Level 3 Surgical Face Masks with Tie On is FXX.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07155863The Effect of Sensory Isolation on Anxiety in Magnetic Resonance ImagingCOMPLETED NCT07586098AI-assisted Diagnosis, Triage and Assessment of Hearing Loss and TinnitusNOT_YET_RECRUITING

Other records listing Dukal Corporation as applicant

K252823Dukal Crepe Paper Sterilization Wrap K233262Dukal SMS Sterilization Wrap K212464Dukal Corporation AAMI Level 4 Open-Back Protective Gown K210321Dukal Corporation Level 1 Pediatric Face Mask K203237Dukal Sterile AAMI Level 3 Reinforced Surgical Gown, Sterile AAMI Level 3 Surgical Gown, Sterile AAMI Level 4 Surgical Gown, and Sterile AAMI Level 4 Splicing Surgical Gown K201421Dukal Corporation Level 2 Surgical Mask with Ear Loops; Dukal Corporation Level 2 Surgical Mask with Ear Loops and Face Shield; Dukal Corporation Level 2 Surgical Mask with Adjustable Tie Ons

View all 7 devices →

Related Devices (Code: FXX)

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.K252534Surgical Face Mask (Ear mount)Zhejiang Hangkang Medical Equipment Co., Ltd.K253398Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)Efofex, Inc.K252830Disposable Surgical Face Mask (3P00B, C2900)Beatles Medical Supplies (Xiantao) Co., Ltd.K252650Disposable Medical Face MaskMakrite Industries, Inc.K243342KP Protective Face MaskKp Trading Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.