Duns Number:027532357
Catalog Number
-
Brand Name
Latex Exam XL PF Txt Gloves (100)
Version/Model Number
72720620
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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)
-
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
7696af1b-91d1-4fbb-988c-cedc58460121
Public Version Date
June 19, 2020
Public Version Number
2
DI Record Publish Date
April 24, 2019
Package DI Number
00815878022036
Quantity per Package
100
Contains DI Package
00815878022029
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 214 |
2 | A medical device with a moderate to high risk that requires special controls. | 43 |