Catalog Number

SPK-BLNF

Brand Name

SemperForce Blue Nitrile Exam Glove

Version/Model Number

SPK-BKLF

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)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K171378,K171378

Product Code

LZA

Product Code Name

Polymer Patient Examination Glove

Public Device Record Key

4a72c3a2-dc01-4031-aa65-bed23cdf2655

Public Version Date

May 05, 2021

Public Version Number

3

DI Record Publish Date

July 10, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-