LAITEST Medical Face Mask

FDA 510(k) K214035 · R&R Medical Corporation, Ltd.

Substantially Equivalent

510(k) numberK214035

Submission

Device name
LAITEST Medical Face Mask
Applicant
R&R Medical Corporation, Ltd.
New Taipei City, TW
Received
December 23, 2021
Decision date
September 13, 2022
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
FXX – Mask, Surgical
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4040
Specialty
General, Plastic Surgery

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K252964PRIMED Surgical and Procedure MasksFXX · Traditional Primed Medical Products, Inc.11/04/2025SE
K251902Vitaform Procedural Mask - Blue (Vitaform Blue); Vitaform Procedural Mask with Shield…FXX · Traditional Vitacore Industries, Inc.09/17/2025SE
K250082Procedure mask/Surgical mask/Face maskFXX · Traditional Winner Medical Co., Ltd.06/18/2025SE

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Questions and answers

When was LAITEST Medical Face Mask cleared by the FDA?

LAITEST Medical Face Mask (K214035) received a 510(k) decision of Substantially Equivalent on September 13, 2022, 264 days after the submission was received.

What is the product code of K214035?

The FDA product code is FXX – Mask, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.4040.