Catalog Number

-

Brand Name

TravelShield

Version/Model Number

L

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

Yes

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

K110981,K110981

Product Code

LZA

Product Code Name

Polymer Patient Examination Glove

Public Device Record Key

d92cc684-117d-4d22-b8f7-8f93e6fecae7

Public Version Date

September 28, 2022

Public Version Number

1

DI Record Publish Date

September 20, 2022

Package DI Number

10342509000103

Quantity per Package

50

Contains DI Package

00342509000106

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case