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Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap Shield

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K171162

by Prestige Ameritech

Identifiers

510(k) Number
K171162 FDA 510(k)
FDA Product Code
FXX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4040 FDA 510(k)
Regulation Number
878.4040 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is a surgical face mask designed to provide enhanced barrier protection against splashes and sprays. It combines an earloop and tie-on styles with an integrated bottom gap shield to reduce exposure risks, particularly for healthcare personnel and patients in controlled environments like operating rooms, dental clinics, and isolation settings.

The masks are single-use, disposable, and supplied in sterile packaging (40/box). They are classified under FDA 510(k) clearance (K171162) and meet MDR requirements, ensuring compliance with regulatory standards for surgical use. No MRI safety or reusable specifications are indicated in the data.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On ..., Surgical Earloop Face Masks with Bottom Gap Shield 40/Box, Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On ...

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Prestige Ameritech

Sources (2)

  • FDA 510(k) K171162 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026