Duns Number:007900020
Device Description: LATEX HIGH RISK POWDER FREE GLOVES 13 MIL BLUE, 10/50, MED
Catalog Number
GDLPF101M
Brand Name
Hand Armor
Version/Model Number
GDLPF101M
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)
Yes
Device labeled as "Not made with natural rubber latex"
-
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
LYY
Product Code Name
Latex Patient Examination Glove
Public Device Record Key
00b0e0e0-2dbc-4ff7-8804-885671b04741
Public Version Date
June 19, 2020
Public Version Number
2
DI Record Publish Date
April 20, 2020
Package DI Number
10787081114334
Quantity per Package
10
Contains DI Package
00787081114337
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |