Duns Number:007941230
Device Description: Glove Exam Large Beaded 9.5 Inch Cuff Ambidextrous Powder-free Textured Cleared For Use Wi Glove Exam Large Beaded 9.5 Inch Cuff Ambidextrous Powder-free Textured Cleared For Use With Some Chemotherapy Drugs Extra-large MediChoice
Catalog Number
-
Brand Name
MediChoice
Version/Model Number
GLV2504
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
LZA
Product Code Name
Polymer patient examination glove
Public Device Record Key
699276f2-365d-4011-903f-a5d8ee8d1934
Public Version Date
October 07, 2020
Public Version Number
1
DI Record Publish Date
September 29, 2020
Package DI Number
30885632146941
Quantity per Package
10
Contains DI Package
20885632146944
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 |