Duns Number:017524666
Device Description: ChloroSense Polychloroprene Surgical Gloves, Non-Latex and Powder Free. Sterile by Gamma ChloroSense Polychloroprene Surgical Gloves, Non-Latex and Powder Free. Sterile by Gamma R. Size 6.5. pair.
Catalog Number
-
Brand Name
AD Surgical
Version/Model Number
A501-C65
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)
-
Device labeled as "Not made with natural rubber latex"
Yes
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
KGO
Product Code Name
Surgeon'S Gloves
Public Device Record Key
4e2068c9-f1ba-4126-9955-058781f9216e
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 22, 2016
Package DI Number
10814639023098
Quantity per Package
50
Contains DI Package
00814639023091
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 | 73 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 121 |