Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Disposable Medical Face Mask (DF3-001)

K-Number: K222697 · 2022-11-04

ApplicantWellmed Dental Medical Supply Co., Ltd.
Decision Date2022-11-04
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Disposable Medical Face Mask (DF3-001) is the device name listed in this FDA 510(k) record. The listed applicant is Wellmed Dental Medical Supply Co., Ltd.. It received FDA 510(k) clearance on 2022-11-04 under 510(k) number K222697. 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 Disposable Medical Face Mask (DF3-001)?

Disposable Medical Face Mask (DF3-001) is a medical device that received FDA 510(k) clearance on 2022-11-04. The listed applicant is Wellmed Dental Medical Supply Co., Ltd.. The 510(k) number is K222697.

When did Disposable Medical Face Mask (DF3-001) receive FDA 510(k) clearance?

Disposable Medical Face Mask (DF3-001) received FDA 510(k) clearance on 2022-11-04, under 510(k) number K222697.

Who is the listed applicant for Disposable Medical Face Mask (DF3-001)?

The FDA 510(k) record lists Wellmed Dental Medical Supply Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Medical Face Mask (DF3-001)?

The FDA product code for Disposable Medical Face Mask (DF3-001) is FXX.

Other records listing Wellmed Dental Medical Supply Co., Ltd. as applicant

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.

K243721Self Sealing Sterilization PouchesK242435Dental Barrier and Sleeves

Related Devices (Code: FXX)

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.

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.

↑