Catalog Number

72-90604

Brand Name

Bosma Enterprises

Version/Model Number

72-90604

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

K070076,K070076,K070076

Product Code

LYZ

Product Code Name

Vinyl Patient Examination Glove

Public Device Record Key

ed40f8ca-fd76-46af-852e-3149e4793323

Public Version Date

July 12, 2021

Public Version Number

1

DI Record Publish Date

July 02, 2021

Package DI Number

30818634020063

Quantity per Package

10

Contains DI Package

20818634020066

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case