← Back to catalogue

PRIMAGARD DELTA FIT 80, 120, 160 SURGICAL FACE MASK - Pg4-7061

FDA 510(k)

Class II (US FDA 510(k))

510(k) K092012

by Primed Medical Products Inc.

Identifiers

510(k) Number
K092012 FDA 510(k)
FDA Product Code
FXX FDA 510(k)
Models / Variants
Pg4-7061 FDA 510(k)
-7071 FDA 510(k)
-7081 FDA 510(k)
Pg4-7062 FDA 510(k)
7072-70 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)

The Primagard Delta Fit 80, 120, 160 Surgical Face Mask is a surgical face mask designed to protect both the patient and clinician from fluids and particles generated during surgery. It also protects the patient's surgical site from contamination from the clinician, such as droplets from talking or coughing.

This device is supplied in small, medium, and large sizes and is identified by the model numbers PG4-7061, -7071, -7081, PG4-7062, and 7072-70. It received FDA 510(k) clearance under k-number K092012 and is classified under product code FXX. The device is manufactured by Primed Medical Products Inc. in Edmonton, Alberta, Canada.

Frequently asked questions

What is the Primagard Delta Fit 80, 120, 160 Surgical Face Mask used for?

The Primagard Delta Fit 80, 120, 160 Surgical Face Mask is designed to protect both the patient and clinician from fluids and particles generated during surgery. It also protects the patient's surgical site from contamination by droplets from the clinician's talking or coughing, as stated in the device description.

How is the Primagard Delta Fit 80, 120, 160 Surgical Face Mask supplied and what sizes are available?

The device is supplied in small, medium, and large sizes. It is identified by the model numbers PG4-7061, -7071, -7081, PG4-7062, and 7072-70, which correspond to the different size variants as listed in the device name and specifications.

Is the Primagard Delta Fit 80, 120, 160 Surgical Face Mask sterile or single-use?

The device data does not specify whether the mask is sterile or single-use. Therefore, no conclusion can be drawn about its sterility or reusability based solely on the provided information, which focuses on its design, sizes, model numbers, and regulatory clearance.

What regulatory pathway was used for the Primagard Delta Fit 80, 120, 160 Surgical Face Mask?

The device received FDA 510(k) clearance under k-number K092012, as explicitly stated in the description and specifications. This indicates it was cleared via the 510(k) premarket notification process, demonstrating substantial equivalence to a legally marketed predicate device.

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: priMED PRIMAGARD® 80 Surgical Tie Mask - Bowers Medical Supply, priMED PRIMAGARD® 80 Surgical Tie Mask with Anti-Fog Foam, Surgical Tie Masks | Facial Protection | PRIMED Medical Products, Inc.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Primed Medical Products Inc.
FDA Applicant
Primed Medical Products, Inc.

Sources (1)

  • FDA 510(k) K092012 24 fields · synced Oct 6, 2026