Duns Number:779982974
Device Description: CHLOROPRENE EXAMINATION GLOVES POWDER FREE AVOCADO GREEN (X-SMALL)
Catalog Number
BM 97325-CHL-LG-PF
Brand Name
BLOSSOM
Version/Model Number
BM 97325-CHL-LG-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)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
OPC
Product Code Name
Powder-Free Polychloroprene Patient Examination Glove
Public Device Record Key
3273cab9-801a-40e3-a805-25359d0f467f
Public Version Date
March 03, 2022
Public Version Number
1
DI Record Publish Date
February 23, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 177 |
2 | A medical device with a moderate to high risk that requires special controls. | 13 |