Duns Number:421353735
Device Description: Powder-free textured; The packages of proposed device including middle box package and out Powder-free textured; The packages of proposed device including middle box package and outer carton package. Middle box package quantity: 100PCS Outer carton package quantity: 2000PCS
Catalog Number
-
Brand Name
Examination gloves – Type A (Latex 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)
Yes
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
K214017,K214017,K214017
Product Code
LYY
Product Code Name
Latex Patient Examination Glove
Public Device Record Key
1ca237b8-3394-4363-9f2a-2786013b4f70
Public Version Date
August 18, 2022
Public Version Number
1
DI Record Publish Date
August 10, 2022
Package DI Number
26972267280359
Quantity per Package
20
Contains DI Package
16972267280352
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-