Protection Plus Earloop Procedure Mask
by Safety-Med Products, Inc. 510(k)
Active
510(k) K042654
Overview
The Protection Plus Earloop Procedure Mask is a medical device designed to provide a barrier for the wearer. It is intended to be used during procedures to help protect against the transmission of fluids and particles.
This device has received FDA 510(k) clearance under the reference number K042654. It is supplied by Safety-Med Products, Inc. for use in clinical settings.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK042654 | Date17 Dec 2004 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- FXX
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4040
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Questions
What is the intended use of the Protection Plus Earloop Procedure Mask?
This mask is designed to serve as a barrier for the wearer during clinical procedures. Its primary function is to help protect against the transmission of fluids and particles in a medical environment.
Has this device received regulatory clearance?
Yes, the Protection Plus Earloop Procedure Mask has received FDA 510(k) clearance. It is identified under the reference number K042654, which indicates it has been found substantially equivalent to predicate devices.
Who is the manufacturer of this procedure mask?
The Protection Plus Earloop Procedure Mask is manufactured and supplied by Safety-Med Products, Inc., located in Burlington, Wisconsin.