Catalog Number

NGPF32LBX502

Brand Name

Safe .R World

Version/Model Number

3.2 g. Large

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

K071910,K071910,K071910

Product Code

LZA

Product Code Name

Polymer Patient Examination Glove

Public Device Record Key

bde16cd7-d8b6-4aa0-97b4-67d825b0c1f6

Public Version Date

August 17, 2022

Public Version Number

1

DI Record Publish Date

August 09, 2022

Package DI Number

00860009069954

Quantity per Package

10

Contains DI Package

00860008943217

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case