Catalog Number

-

Brand Name

Bulline

Version/Model Number

B3504

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"

Yes

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

K110981,K110981

Product Code

LZA

Product Code Name

Polymer Patient Examination Glove

Public Device Record Key

b9053d40-9f03-4adc-995a-eeee354c27e4

Public Version Date

October 25, 2022

Public Version Number

1

DI Record Publish Date

October 17, 2022

Package DI Number

00850044093083

Quantity per Package

10

Contains DI Package

00850044093038

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case