Catalog Number

-

Brand Name

Snow Lotus

Version/Model Number

S

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

K010947,K010947,K010947

Product Code

LYY

Product Code Name

Latex Patient Examination Glove

Public Device Record Key

59f9a149-16aa-4659-8391-4c6a864fb2ff

Public Version Date

September 27, 2021

Public Version Number

1

DI Record Publish Date

September 18, 2021

Package DI Number

16936610210038

Quantity per Package

10

Contains DI Package

06936610210031

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX