Duns Number:062388929
Device Description: Nitrile Chemo Tested Exam Gloves, Powder Free, Size Extra Large (XL), Blue
Catalog Number
1005
Brand Name
Strong Manufacturers
Version/Model Number
1005
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)
Yes
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
a420b18e-3f09-44d6-8048-05a8c3186e01
Public Version Date
September 20, 2021
Public Version Number
1
DI Record Publish Date
September 10, 2021
Package DI Number
10853927007044
Quantity per Package
1800
Contains DI Package
00853927007047
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 79 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |