Duns Number:008124539
Device Description: Sterile Nitrile Surgical Gloves, Cuffed and Powder-Free, 1 Pair per Package, Hand Specific Sterile Nitrile Surgical Gloves, Cuffed and Powder-Free, 1 Pair per Package, Hand Specific, Size 7
Catalog Number
-
Brand Name
Sterile Nitrile Surgical Gloves
Version/Model Number
6535
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"
-
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
K122557,K122557,K122557
Product Code
KGO
Product Code Name
Surgeon'S Gloves
Public Device Record Key
88c60558-a3f1-49ee-872e-cf976f8f8961
Public Version Date
May 02, 2022
Public Version Number
1
DI Record Publish Date
April 22, 2022
Package DI Number
00616784653525
Quantity per Package
50
Contains DI Package
00616784653518
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 | 694 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 226 |
| 3 | A medical device with high risk that requires premarket approval | 2 |