Duns Number:025460908
Device Description: GLOVE TRAY 9.0 (15 PR)
Catalog Number
DYNJ61964A
Brand Name
Medline Industries, Inc.
Version/Model Number
DYNJ61964A
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)
Yes
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KGO
Product Code Name
Surgeon's gloves
Public Device Record Key
55f155d9-0a75-454d-9057-dc9dc708e22f
Public Version Date
June 17, 2022
Public Version Number
2
DI Record Publish Date
September 05, 2021
Package DI Number
40193489968690
Quantity per Package
25
Contains DI Package
10193489968699
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 | 38540 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 85094 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 7 |