Duns Number:054386458
Device Description: 4.5mil, 9.5" in Length, Nitrile, Examination Grade, Ambidextrous, Single Use, Micro-Textur 4.5mil, 9.5" in Length, Nitrile, Examination Grade, Ambidextrous, Single Use, Micro-Textured Finish, Powder Free, Beaded Cuff, Blue, Size 2X-Large
Catalog Number
-
Brand Name
NitriTech
Version/Model Number
76760PF-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
K990878,K990878,K990878
Product Code
LZA
Product Code Name
Polymer patient examination glove
Public Device Record Key
4f1289ea-315b-462f-8105-7f9e576ce4db
Public Version Date
November 30, 2020
Public Version Number
2
DI Record Publish Date
August 01, 2020
Package DI Number
10850018374702
Quantity per Package
10
Contains DI Package
00850018374705
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 |