Duns Number:054386458
Device Description: 11.5mil, 13" in Length, Nitrile, Examination Grade, Ambidextrous, Unlined, Raised Diamond 11.5mil, 13" in Length, Nitrile, Examination Grade, Ambidextrous, Unlined, Raised Diamond Pattern, Beaded Cuff, Blue, Size X-Large
Catalog Number
-
Brand Name
AmbiNitrile
Version/Model Number
570-BL-10
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
K990878,K990878,K990878
Product Code
LZA
Product Code Name
Polymer patient examination glove
Public Device Record Key
eae849e4-a7e3-4941-8a4b-71ac9af9dcf9
Public Version Date
November 30, 2020
Public Version Number
2
DI Record Publish Date
August 01, 2020
Package DI Number
10850018374160
Quantity per Package
24
Contains DI Package
00850018374163
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 |