Duns Number:828690904
Device Description: X-Large, Soft, nitrile powder-free, Textured fingertips, Packaging contains recycled mater X-Large, Soft, nitrile powder-free, Textured fingertips, Packaging contains recycled material, Blue in color
Catalog Number
1024005
Brand Name
PureGuard
Version/Model Number
1024005
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K081592,K081592,K081592
Product Code
LZA
Product Code Name
Polymer Patient Examination Glove
Public Device Record Key
d79584cf-3e2d-4d02-b9f7-d8030bb52dfd
Public Version Date
April 02, 2021
Public Version Number
1
DI Record Publish Date
March 25, 2021
Package DI Number
D79010240053
Quantity per Package
1000
Contains DI Package
D79010240051
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 | 4 |