Catalog Number

62823-00

Brand Name

KIMTECH SPECTRUM NITRILE POWDER FREE EXAM GLOVES (XL)

Version/Model Number

62823

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

K990878,K990878,K990878

Product Code

LZA

Product Code Name

Polymer patient examination glove

Public Device Record Key

1b8810b1-208f-4a0b-b4d0-dc51dd9ebb0f

Public Version Date

November 30, 2020

Public Version Number

2

DI Record Publish Date

November 10, 2020

Package DI Number

10036000628231

Quantity per Package

10

Contains DI Package

00036000628234

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case