Duns Number:943016071
Device Description: S-GEN Powder-Free Nitrile Examination Gloves, Size XL, 200
Catalog Number
44-104XL
Brand Name
NEXT-GEN
Version/Model Number
44-104XL
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
f7692f92-d131-4dce-9066-d5e7ede54657
Public Version Date
August 26, 2022
Public Version Number
1
DI Record Publish Date
August 18, 2022
Package DI Number
00850043811695
Quantity per Package
10
Contains DI Package
00850043811480
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-