Catalog Number

-

Brand Name

Protect U Guard Nitro-Lion Nitrile Patient Examination Glove

Version/Model Number

P10104

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K170397,K170397

Product Code

LZA

Product Code Name

Polymer Patient Examination Glove

Public Device Record Key

093e30b1-b6d9-42b0-8d5b-1b2e192da84a

Public Version Date

June 19, 2020

Public Version Number

4

DI Record Publish Date

January 02, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-