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

FDA 510(k)

Defender Safety Procedure Mask Level 1, Defender Safety Procedure Mask Level 3, Defender Safety Surgical Mask Level 3

K-Number: K210705 · 2021-05-06

Decision Date2021-05-06
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Defender Safety Procedure Mask Level 1, Defender Safety Procedure Mask Level 3, Defender Safety Surgical Mask Level 3 is a medical device manufactured by Defender Safety, Inc.. It received FDA 510(k) clearance on 2021-05-06 under approval number K210705. 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 Defender Safety Procedure Mask Level 1, Defender Safety Procedure Mask Level 3, Defender Safety Surgical Mask Level 3?

Defender Safety Procedure Mask Level 1, Defender Safety Procedure Mask Level 3, Defender Safety Surgical Mask Level 3 is a medical device that received FDA 510(k) clearance on 2021-05-06. It is manufactured by Defender Safety, Inc.. The 510(k) number is K210705.

When was Defender Safety Procedure Mask Level 1, Defender Safety Procedure Mask Level 3, Defender Safety Surgical Mask Level 3 approved by the FDA?

Defender Safety Procedure Mask Level 1, Defender Safety Procedure Mask Level 3, Defender Safety Surgical Mask Level 3 received FDA 510(k) clearance on 2021-05-06, under approval number K210705.

What company makes Defender Safety Procedure Mask Level 1, Defender Safety Procedure Mask Level 3, Defender Safety Surgical Mask Level 3?

Defender Safety Procedure Mask Level 1, Defender Safety Procedure Mask Level 3, Defender Safety Surgical Mask Level 3 is manufactured by Defender Safety, Inc..

What is the FDA product code for Defender Safety Procedure Mask Level 1, Defender Safety Procedure Mask Level 3, Defender Safety Surgical Mask Level 3?

The FDA product code for Defender Safety Procedure Mask Level 1, Defender Safety Procedure Mask Level 3, Defender Safety Surgical Mask Level 3 is FXX.

Related Clinical Trials

Related PubMed Literature

Other Devices by Defender Safety, Inc.

Related Devices (Code: FXX)

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.