KIMTECH STERLING NITRILE EXAM GLOVES (L) - Examination Gloves - KIMBERLY-CLARK GLOBAL SALES, LLC

Duns Number:830997032

Device Description: Examination Gloves

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More Product Details

Catalog Number

50708-54

Brand Name

KIMTECH STERLING NITRILE EXAM GLOVES (L)

Version/Model Number

50708

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 15, 2020

Issuing Agency

In GS1

Product Characteristics

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

K081089,K081089,K081089

Product Code Details

Product Code

LZC

Product Code Name

Patient examination glove, specialty

Device Record Status

Public Device Record Key

af9b52a1-4b8f-46bd-ac0f-16c7d2898cdc

Public Version Date

June 19, 2020

Public Version Number

3

DI Record Publish Date

March 13, 2020

Additional Identifiers

Package DI Number

10036018507085

Quantity per Package

10

Contains DI Package

00036018507088

Package Discontinue Date

April 15, 2020

Package Status

Not in Commercial Distribution

Package Type

Case

"KIMBERLY-CLARK GLOBAL SALES, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1