Duns Number:627572217
Device Description: CUSTOMFEEL LATEX POWDERED SURGICAL GLOVE 8.5
Catalog Number
9003052
Brand Name
CUSTOMED
Version/Model Number
712057693052
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
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
K010198,K010198,K010198,K010198
Product Code
KGO
Product Code Name
Surgeon'S Gloves
Public Device Record Key
00d1dd66-b001-4a93-97ef-3ea0bd8951fd
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 23, 2016
Package DI Number
M20890030521
Quantity per Package
50
Contains DI Package
M20890030527
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
50PR/BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |