Duns Number:421353735
Device Description: Powder-free textured;The packages of proposed device including immediate package, middle b Powder-free textured;The packages of proposed device including immediate package, middle box package and outer carton package.Immediate package quantity: 1 pairMiddle box package quantity: 50 pairsOuter carton package quantity: 400 pairs
Catalog Number
-
Brand Name
Disposable Sterilized Latex Surgical Gloves
Version/Model Number
6.5
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
K211953,K211953,K211953
Product Code
KGO
Product Code Name
Surgeon'S Gloves
Public Device Record Key
146a442b-ac47-4b2b-94bf-3fc250e668ce
Public Version Date
July 26, 2022
Public Version Number
1
DI Record Publish Date
July 18, 2022
Package DI Number
16972267280109
Quantity per Package
50
Contains DI Package
06972267280102
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-