Catalog Number

72-10504

Brand Name

Bosma Enterprises

Version/Model Number

72-10504

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

K042226,K183562,K042226,K183562,K042226,K183562

Product Code

LZA

Product Code Name

Polymer Patient Examination Glove

Public Device Record Key

3ea9f747-f82c-4fd1-8a7f-ac0e3beb6334

Public Version Date

July 12, 2021

Public Version Number

1

DI Record Publish Date

July 02, 2021

Package DI Number

30818634020216

Quantity per Package

10

Contains DI Package

20818634020219

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case