Catalog Number

SG805085

Brand Name

LATEX POLYMER POWDER FREE SURGICAL GLOVES (PALM TEXTURE) SIZE 8.5, PAIR

Version/Model Number

SG805085

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)

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

-

Product Code

KGO

Product Code Name

Surgeon'S Gloves

Public Device Record Key

f7680a1c-9c4a-48b8-8e6d-138b8f898312

Public Version Date

June 19, 2020

Public Version Number

2

DI Record Publish Date

May 02, 2020

Package DI Number

10812460026691

Quantity per Package

50

Contains DI Package

00812460026694

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Box