Duns Number:527852220
Device Description: Powder Free Vinyl Patient Examination Glove, Clear, Medium – 100/box
Catalog Number
-
Brand Name
Hongray
Version/Model Number
M
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"
-
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
LYZ
Product Code Name
Vinyl Patient Examination Glove
Public Device Record Key
2840dd6e-28e9-418c-953e-0ed6626e11c8
Public Version Date
May 09, 2022
Public Version Number
1
DI Record Publish Date
May 01, 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 | 48 |