Duns Number:782216881
Device Description: SMC Blue PF Latex Exam Gloves, Large, 50/bx, 10bxs/cs
Catalog Number
SMCB-L
Brand Name
SMC Blue
Version/Model Number
SMCB-L
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
30310966-22c5-4052-bf58-896fa1bfa857
Public Version Date
September 13, 2022
Public Version Number
1
DI Record Publish Date
September 05, 2022
Package DI Number
10860003676148
Quantity per Package
10
Contains DI Package
00860003676141
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box