Duns Number:080070945
Device Description: Nitrile Patient Examination Glove, Indigo, Small
Catalog Number
-
Brand Name
Protect U Guard Nitro-Lion Nitrile Patient Examination Glove
Version/Model Number
P10101
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K170397,K170397
Product Code
LZA
Product Code Name
Polymer Patient Examination Glove
Public Device Record Key
1ae188d3-46c5-4ff8-8571-3d48bc28bd96
Public Version Date
June 19, 2020
Public Version Number
4
DI Record Publish Date
January 02, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-