Duns Number:017524666
Device Description: ChloroSense Polychloroprene Surgical Gloves, Non-Latex and Powder Free. Sterile. Size 8. ChloroSense Polychloroprene Surgical Gloves, Non-Latex and Powder Free. Sterile. Size 8.0 (pair).
Catalog Number
-
Brand Name
AD Surgical
Version/Model Number
A501-C80
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
290094a3-0ddd-4ac7-9a28-aca9756c1db8
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 22, 2016
Package DI Number
10814639023128
Quantity per Package
50
Contains DI Package
00814639023121
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 |