Duns Number:062388929
Device Description: Black Nitrile Exam Gloves - Platinum Series, Powder Free, Size Large (L)
Catalog Number
1604
Brand Name
Strong Manufacturers
Version/Model Number
1604
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
K133307,K133307
Product Code
LZA
Product Code Name
Polymer Patient Examination Glove
Public Device Record Key
cca7d4c8-4f41-4319-ad9e-3532d6e061e1
Public Version Date
December 22, 2021
Public Version Number
1
DI Record Publish Date
December 10, 2021
Package DI Number
10850005354595
Quantity per Package
1000
Contains DI Package
00850005354598
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 |