Duns Number:010206618
Device Description: Shamrock Supreme 30350 Nitrile Examination Powder Free Textured Gloves, Blue, Medium, Box Shamrock Supreme 30350 Nitrile Examination Powder Free Textured Gloves, Blue, Medium, Box of 100
Catalog Number
-
Brand Name
Shamrock
Version/Model Number
30352/100
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
K052382,K052382
Product Code
LZA
Product Code Name
Polymer Patient Examination Glove
Public Device Record Key
89a2119a-d2e1-4f2b-a204-b32088ab9d9c
Public Version Date
May 18, 2021
Public Version Number
1
DI Record Publish Date
May 10, 2021
Package DI Number
10641932303523
Quantity per Package
10
Contains DI Package
00641932303526
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 | 21 |