Catalog Number

-

Brand Name

Snow Lotus

Version/Model Number

5.5

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

K012104,K012104,K012104

Product Code

KGO

Product Code Name

Surgeon'S Gloves

Public Device Record Key

f5dcb360-d43e-4248-8caa-5ca829975e85

Public Version Date

September 27, 2021

Public Version Number

1

DI Record Publish Date

September 18, 2021

Package DI Number

16936610210144

Quantity per Package

50

Contains DI Package

06936610210147

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

small box