Duns Number:020417380
Device Description: Safco EZ Green Chloroprene gloves Small 200/box
Catalog Number
1028048
Brand Name
Safco EZ Green Chloroprene
Version/Model Number
1028048
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LZA
Product Code Name
Polymer patient examination glove
Public Device Record Key
fb98edb2-92a4-4b12-8725-097ed078cd06
Public Version Date
October 15, 2021
Public Version Number
1
DI Record Publish Date
October 07, 2021
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 |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 600 |
2 | A medical device with a moderate to high risk that requires special controls. | 23 |