Duns Number:134472476
Device Description: NITRILE, CHEMO RATED, EXAM GLOVE, POWDER FREE, NON STERILE, MEDIUM SIZE
Catalog Number
-
Brand Name
Regard™
Version/Model Number
NTRLCHMGLVM1-REG
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
K181857,K181857
Product Code
LZA
Product Code Name
Polymer Patient Examination Glove
Public Device Record Key
abc87daf-dd7f-4b70-8a73-3eb21726d460
Public Version Date
September 22, 2020
Public Version Number
1
DI Record Publish Date
September 14, 2020
Package DI Number
10326053117821
Quantity per Package
10
Contains DI Package
00326053117824
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 305 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 558 |