Duns Number:111267330
Device Description: MICROFLEX Aloe Sense Pink XL (9.5-10), Aloe & Chamomile Coated Nitrile Powder-Free Examina MICROFLEX Aloe Sense Pink XL (9.5-10), Aloe & Chamomile Coated Nitrile Powder-Free Examination Glove
Catalog Number
93849100
Brand Name
MICROFLEX
Version/Model Number
93849100
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
c4e51736-130d-49cc-a92f-4ed85ba49cfe
Public Version Date
March 23, 2022
Public Version Number
1
DI Record Publish Date
March 15, 2022
Package DI Number
20076490432298
Quantity per Package
10
Contains DI Package
10076490432291
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 36 |