Catalog Number

-

Brand Name

Gloves

Version/Model Number

12890

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

K141303,K141303,K141303

Product Code

LZA

Product Code Name

Polymer Patient Examination Glove

Public Device Record Key

2d4260e7-13b0-4fce-bee0-4f1ca32c1079

Public Version Date

June 19, 2020

Public Version Number

2

DI Record Publish Date

September 01, 2019

Package DI Number

00369771001433

Quantity per Package

10

Contains DI Package

00369771001426

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case