Duns Number:828690904
Device Description: X-Small, Very soft, stretchy nitrile, Textured fingertips, Blue in color, Packaging contai X-Small, Very soft, stretchy nitrile, Textured fingertips, Blue in color, Packaging contains recycled material
Catalog Number
1067301
Brand Name
PureHorizon
Version/Model Number
1067301
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
K110960,K110960,K110960
Product Code
LZA
Product Code Name
Polymer Patient Examination Glove
Public Device Record Key
03ebb977-8d87-4cbd-bc9f-3f3f61364e3e
Public Version Date
April 05, 2021
Public Version Number
1
DI Record Publish Date
March 26, 2021
Package DI Number
D79010673013
Quantity per Package
2000
Contains DI Package
D79010673011
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 |