Duns Number:080344373
Device Description: Nitrile examination/treatment glove, non-powdered, non-antimicrobial Size: XL Pack: 100 pi Nitrile examination/treatment glove, non-powdered, non-antimicrobial Size: XL Pack: 100 pieces by weight / inner box.
Catalog Number
-
Brand Name
Stronghold Group Nitrile Examination Glove, Powder Free-XL
Version/Model Number
SHFBSNS0603XL
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)
-
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
25ffb3b2-80c5-44fc-9fd3-5990f2396b21
Public Version Date
March 16, 2022
Public Version Number
1
DI Record Publish Date
March 08, 2022
Package DI Number
00860007372278
Quantity per Package
10
Contains DI Package
00860007372230
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 15 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |