Duns Number:117537165
Device Description: Case of 3-Ply, single use, disposable surgical face masks with an ASTM Level 3 rating. Ma Case of 3-Ply, single use, disposable surgical face masks with an ASTM Level 3 rating. Made with elastic ear loops that do not contain natural rubber latex.
Catalog Number
-
Brand Name
ASTM Level 3 Surgical Face Mask
Version/Model Number
20-1002-SFM3
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K202595
Product Code
FXX
Product Code Name
Mask, Surgical
Public Device Record Key
13ba80cb-36af-46b8-923b-87ae6f4810dd
Public Version Date
June 27, 2022
Public Version Number
2
DI Record Publish Date
April 22, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |