Duns Number:207372814
Device Description: Customer focused packaging with attractive, easy to read boxes.Flexible packaging allowing Customer focused packaging with attractive, easy to read boxes.Flexible packaging allowing vertical or horizontal merchandising increasing shop-ability while reducing shelf and storage spaceErgonomic opening to avoid wasteRecyclable packagingComfortable fitLatex-free and powder-free for low allergy or dermatitis potentialBeaded cuff to prevent roll-downSnug fit for good sensation and gripMeets or exceeds ASTM standards for Medical Exam glovesIdeal for use with chemicals that will compromise vinyl and latex glovesASTM F1671 - Penetration by Blood-Borne PathogensASTM D6319 - Specification for Nitrile Examination Gloves for Medical ApplicationChemotherapy tested using ASTM D6978
Catalog Number
-
Brand Name
OmniFLEX™ Powder-Free Nitrile Medical Examination Gloves
Version/Model Number
012-117
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)
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
K110981,K110981
Product Code
LZA
Product Code Name
Polymer Patient Examination Glove
Public Device Record Key
b0547214-65d7-49df-91b1-8fc93ac64d87
Public Version Date
September 23, 2020
Public Version Number
1
DI Record Publish Date
September 15, 2020
Package DI Number
10057565121173
Quantity per Package
10
Contains DI Package
00057565121176
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Master Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |