Catalog Number

-

Brand Name

Gloves

Version/Model Number

12892

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

c640b3e8-2566-4669-b1b8-d38fa10e8d49

Public Version Date

June 19, 2020

Public Version Number

2

DI Record Publish Date

September 01, 2019

Package DI Number

00369771001457

Quantity per Package

10

Contains DI Package

00369771001440

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case