Duns Number:078572603
Device Description: Nitrile Examination Gloves, 3.7g, Low Dermatitis, Chemo Rated, Fentanyl Protection, Powder Nitrile Examination Gloves, 3.7g, Low Dermatitis, Chemo Rated, Fentanyl Protection, Powder-Free, Non-Sterile, Medium
Catalog Number
-
Brand Name
HCS
Version/Model Number
HCS6605
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LZC
Product Code Name
Patient Examination Glove, Specialty
Public Device Record Key
3d38c65b-caf5-4ad4-a2a6-87245f3c0e41
Public Version Date
June 19, 2020
Public Version Number
2
DI Record Publish Date
December 31, 2019
Package DI Number
10849027000214
Quantity per Package
10
Contains DI Package
00849027000217
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 72 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 30 |