Duns Number:118744421
Device Description: Product: GloveType: ExamMaterial: NitrileSize: MediumFingertip Thickness: 3.5gStandard Cuf Product: GloveType: ExamMaterial: NitrileSize: MediumFingertip Thickness: 3.5gStandard Cuff: 9.5"Powder FreeColor: BlueSPC Code: ST
Catalog Number
STNG001M
Brand Name
CALICO
Version/Model Number
STNG001M
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K200539,K200539
Product Code
LZA
Product Code Name
Polymer Patient Examination Glove
Public Device Record Key
312c000d-4fa1-4fcb-894b-56695fe24edf
Public Version Date
August 08, 2022
Public Version Number
1
DI Record Publish Date
July 29, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |
| U | Unclassified | 1 |