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FDA 510(k)

LAITEST Medical Face Mask

K-Number: K214035 · 2022-09-13

Decision Date2022-09-13
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LAITEST Medical Face Mask is the device name listed in this FDA 510(k) record. The listed applicant is R&R Medical Corporation, Ltd.. It received FDA 510(k) clearance on 2022-09-13 under 510(k) number K214035. 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 LAITEST Medical Face Mask?

LAITEST Medical Face Mask is a medical device that received FDA 510(k) clearance on 2022-09-13. The listed applicant is R&R Medical Corporation, Ltd.. The 510(k) number is K214035.

When did LAITEST Medical Face Mask receive FDA 510(k) clearance?

LAITEST Medical Face Mask received FDA 510(k) clearance on 2022-09-13, under 510(k) number K214035.

Who is the listed applicant for LAITEST Medical Face Mask?

The FDA 510(k) record lists R&R Medical Corporation, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LAITEST Medical Face Mask?

The FDA product code for LAITEST Medical Face Mask is FXX.

Other records listing R&R Medical Corporation, 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.

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.

Official Source

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