Catalog Number

53138-54

Brand Name

KIMTECH STERLING NITRILE Xtra EXAM GLOVES (S)

Version/Model Number

53138

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

K162186,K162186,K162186

Product Code

LZC

Product Code Name

Patient examination glove, specialty

Public Device Record Key

87ed0c93-0bad-45cc-91b6-1bc5201dae45

Public Version Date

September 10, 2020

Public Version Number

3

DI Record Publish Date

March 23, 2020

Package DI Number

10036000531388

Quantity per Package

10

Contains DI Package

00036000531381

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case