Catalog Number

50503-53

Brand Name

KIMTECH PFE-XTRA LATEX EXAM GLOVES (L)

Version/Model Number

50503

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)

-

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

a7a26c9a-6fd7-4a7a-a3cb-9cdf155fee67

Public Version Date

June 19, 2020

Public Version Number

2

DI Record Publish Date

March 13, 2020

Package DI Number

10036000505037

Quantity per Package

10

Contains DI Package

00036000505030

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case