Duns Number:080061451
Device Description: Latex Examination Gloves, Ambidextrous, Non-Powder 9” LargeHEPRO.US – Latex Examination G Latex Examination Gloves, Ambidextrous, Non-Powder 9” LargeHEPRO.US – Latex Examination Gloves – Size Large 100 per Box
Catalog Number
-
Brand Name
HEPRO.US Latex Examination Gloves Size Large
Version/Model Number
BX - Latex Exam Large
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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)
-
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
a6eb896a-01d4-4a48-8247-b16d396d790a
Public Version Date
June 19, 2020
Public Version Number
3
DI Record Publish Date
June 21, 2017
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 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 20 |