Duns Number:111267330
Device Description: MICRO-TOUCH Affinity 313000 Size XS, Neoprene Powder-Free Examination Glove
Catalog Number
3770
Brand Name
MICRO-TOUCH
Version/Model Number
3770
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
bf26f03a-a858-4fc5-bea7-e4fa099dc647
Public Version Date
April 04, 2022
Public Version Number
1
DI Record Publish Date
March 25, 2022
Package DI Number
H726377026
Quantity per Package
10
Contains DI Package
H726377015
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 |