Catalog Number

57440-53

Brand Name

KIMTECH PFE LATEX EXAM GLOVES (L)

Version/Model Number

57440

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)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

LYY

Product Code Name

Latex patient examination glove

Public Device Record Key

3f1bd252-54e4-4202-8836-2ba86b75bd74

Public Version Date

June 19, 2020

Public Version Number

2

DI Record Publish Date

March 13, 2020

Package DI Number

10036000574408

Quantity per Package

10

Contains DI Package

00036000574401

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case