Duns Number:007941230
Device Description: Exam Glove Vinyl, Made With DOTP, 9.5 Inch, Disposable, Non-Sterile, Powder-Free, Ambidext Exam Glove Vinyl, Made With DOTP, 9.5 Inch, Disposable, Non-Sterile, Powder-Free, Ambidextrous, Beaded Cuff, Smooth Finish Large Clear Single Use Only, Not Made With Natural Rubber Latex, MediChoice
Catalog Number
-
Brand Name
Medichoice
Version/Model Number
GLV3103
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LYZ
Product Code Name
Vinyl patient examination glove
Public Device Record Key
ca50d344-df3b-4ce3-9b93-49459ce39a74
Public Version Date
October 07, 2020
Public Version Number
1
DI Record Publish Date
September 29, 2020
Package DI Number
30885632064559
Quantity per Package
10
Contains DI Package
20885632064552
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 428 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8754 |
| U | Unclassified | 1 |