Catalog Number

-

Brand Name

Beesure

Version/Model Number

BE2836

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

K052666,K052666

Product Code

LYY

Product Code Name

Latex Patient Examination Glove

Public Device Record Key

5bb5a469-911c-48c2-812b-95a961e61617

Public Version Date

June 15, 2022

Public Version Number

3

DI Record Publish Date

June 11, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-