Catalog Number

53141-54

Brand Name

KIMTECH STERLING NITRILE XTRA EXAM GLOVES (XL)

Version/Model Number

53141

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

7627778a-6f44-4277-ad25-18a5f05dc006

Public Version Date

September 10, 2020

Public Version Number

3

DI Record Publish Date

March 23, 2020

Package DI Number

10036000531418

Quantity per Package

10

Contains DI Package

00036000531411

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case