Duns Number:080070945
Device Description: Protect U Guard Nitro-Lion LD Nitrile Patient Examination Glove , Single Use, Non-Sterile, Protect U Guard Nitro-Lion LD Nitrile Patient Examination Glove , Single Use, Non-Sterile, Powder Free, Low Dermatitis Potential Box of 250 Gloves
Catalog Number
P10124
Brand Name
Protect U Guard Nitro-Lion LD Nitrile Patient Examination Glove
Version/Model Number
P10124
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
K151824,K151824,K151824
Product Code
LZA
Product Code Name
Polymer Patient Examination Glove
Public Device Record Key
9aef069b-3bb8-4b58-918b-0d36559903d5
Public Version Date
June 19, 2020
Public Version Number
2
DI Record Publish Date
August 27, 2018
Package DI Number
B086201242
Quantity per Package
10
Contains DI Package
B086101241
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton