Catalog Number

71-10401

Brand Name

Bosma Enterprises

Version/Model Number

71-10401

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

K120692,K120692,K120692

Product Code

LYY

Product Code Name

Latex Patient Examination Glove

Public Device Record Key

be3f1ea3-e46c-49f6-ae49-b77287f57035

Public Version Date

July 12, 2021

Public Version Number

1

DI Record Publish Date

July 02, 2021

Package DI Number

60818634020088

Quantity per Package

10

Contains DI Package

50818634020081

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case