Duns Number:007941230
Device Description: Glove Exam Latex 9.5-Inch Cuff Large Non-Sterile Ambidextrous Powder-Free Textured Beaded Glove Exam Latex 9.5-Inch Cuff Large Non-Sterile Ambidextrous Powder-Free Textured Beaded Cuff Disposable Contains Natural Rubber Latex MediChoice
Catalog Number
-
Brand Name
MediChoice
Version/Model Number
GLV1003
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LYY
Product Code Name
Latex patient examination glove
Public Device Record Key
85fb6082-7700-47e3-9767-3c2397582411
Public Version Date
October 13, 2020
Public Version Number
1
DI Record Publish Date
October 05, 2020
Package DI Number
50885632110960
Quantity per Package
10
Contains DI Package
30885632110966
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 |