Catalog Number

-

Brand Name

BYD CARE

Version/Model Number

NE01

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

K212840,K212840

Product Code

LZA

Product Code Name

Polymer Patient Examination Glove

Public Device Record Key

58c24e6a-ae2b-4358-b999-ed9f335aa1a8

Public Version Date

January 06, 2022

Public Version Number

1

DI Record Publish Date

December 29, 2021

Package DI Number

16974528640042

Quantity per Package

10

Contains DI Package

06974528640045

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-