Duns Number:054386458
Device Description: 4mil, 9.5" in Length, Nitrile, Examination Grade, Ambidextrous, Textured Fingertips, Powde 4mil, 9.5" in Length, Nitrile, Examination Grade, Ambidextrous, Textured Fingertips, Powder Free, Aqua Green, Size 2X-Large Sample Pack
Catalog Number
-
Brand Name
NA
Version/Model Number
CRI-550-AG-2XL
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)
-
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
6651e48a-00d9-45ad-b197-1f60fc7bc40f
Public Version Date
August 10, 2020
Public Version Number
1
DI Record Publish Date
August 01, 2020
Package DI Number
10850020255464
Quantity per Package
1200
Contains DI Package
00850020255467
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 12 |