Duns Number:554549693
Device Description: Medical Surgical Mask is intended to be worn to protect both patients and healthcare worke Medical Surgical Mask is intended to be worn to protect both patients and healthcare workers against transfer of microorganisms, body fluids and particulate materials. This is a single use device, provided non-sterile.
Catalog Number
-
Brand Name
ZhengKang
Version/Model Number
ZKM-U01
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"
-
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
K212460,K212460
Product Code
FXX
Product Code Name
Mask, Surgical
Public Device Record Key
3a15494e-7d0d-46b0-8cf3-4a1c9e61a869
Public Version Date
December 14, 2021
Public Version Number
1
DI Record Publish Date
December 06, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-