Duns Number:080388984
Device Description: Honeywell Performance Exam Glove, Chemo, US, SKYBL, Large
Catalog Number
-
Brand Name
Honeywell Performance Exam Glove
Version/Model Number
4580601-L
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
K203236
Product Code
LZA
Product Code Name
Polymer Patient Examination Glove
Public Device Record Key
108e974e-52e9-4a87-a8a5-0cd185e57c9a
Public Version Date
March 07, 2022
Public Version Number
1
DI Record Publish Date
February 25, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 2 |