Duns Number:111267330
Device Description: MICROFLEX BD-100L BLACK DRAGON SIZE XL (9.5-10.0), Black Latex Powder-Free Examination Glo MICROFLEX BD-100L BLACK DRAGON SIZE XL (9.5-10.0), Black Latex Powder-Free Examination Glove
Catalog Number
BD-1004-PF
Brand Name
MICROFLEX
Version/Model Number
BD-1004-PF
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
16109d75-94f4-48a2-93b5-e83a2326a8d7
Public Version Date
March 22, 2022
Public Version Number
1
DI Record Publish Date
March 14, 2022
Package DI Number
00769799190407
Quantity per Package
20
Contains DI Package
00792536666057
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 |