Duns Number:048020664
Device Description: Nitrile examination/treatment glove, non-powdered, non-antimicrobial, single use, 100 coun Nitrile examination/treatment glove, non-powdered, non-antimicrobial, single use, 100 count
Catalog Number
NGPF55LB510
Brand Name
Safe .R World
Version/Model Number
5.5 g Large
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"
-
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
K071910,K071910,K071910
Product Code
LZA
Product Code Name
Polymer Patient Examination Glove
Public Device Record Key
53e89918-ea27-4f3f-bd26-09f1081925c4
Public Version Date
August 17, 2022
Public Version Number
1
DI Record Publish Date
August 09, 2022
Package DI Number
00860009069985
Quantity per Package
10
Contains DI Package
00860008943248
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 | 2 |