Duns Number:117537165
Device Description: 3-ply, single-use disposable surgical mask with a ASTM Level 3 rating. Made with elastic 3-ply, single-use disposable surgical mask with a ASTM Level 3 rating. Made with elastic ear loops that do not contain natural rubber latex. Carton 50 pcs
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,K202595,K202595
Product Code
FXX
Product Code Name
Mask, Surgical
Public Device Record Key
10f40f95-3d8d-4a07-b349-9ad7f1592554
Public Version Date
June 27, 2022
Public Version Number
4
DI Record Publish Date
May 10, 2021
Package DI Number
10850019294016
Quantity per Package
40
Contains DI Package
00850019294019
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |