Duns Number:062388929
Device Description: Nitrile Exam Gloves, Blue, Powder Free, Size Extra Large (XL), Non-Sterile, 1,000 ea per c Nitrile Exam Gloves, Blue, Powder Free, Size Extra Large (XL), Non-Sterile, 1,000 ea per case
Catalog Number
71015
Brand Name
Strong Manufacturers
Version/Model Number
71015
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
f6abe197-86f1-4f60-a52a-a819180b605d
Public Version Date
May 10, 2022
Public Version Number
2
DI Record Publish Date
April 08, 2022
Package DI Number
10853927007532
Quantity per Package
1000
Contains DI Package
00853927007535
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 |