Duns Number:421353735
Device Description: Powder-free textured;The packages of proposed device including middle box package and oute Powder-free textured;The packages of proposed device including middle box package and outer carton package.Middle box package quantity: 100PCSOuter carton package quantity: 1000PCS
Catalog Number
-
Brand Name
Examination gloves – Type C (Nitrile gloves)
Version/Model Number
XL
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K212290,K212290,K212290
Product Code
LZA
Product Code Name
Polymer Patient Examination Glove
Public Device Record Key
e42a417e-5d7a-4373-8d76-c28e2873a323
Public Version Date
August 02, 2022
Public Version Number
1
DI Record Publish Date
July 25, 2022
Package DI Number
26972267280182
Quantity per Package
10
Contains DI Package
16972267280185
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-