Catalog Number

430-N300XL

Brand Name

Health-Tec/DHP Pure Touch Nitrile Gloves

Version/Model Number

430-N300XL

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K001619

Product Code

LZA

Product Code Name

Polymer Patient Examination Glove

Public Device Record Key

04509bc4-5aab-4a6b-990b-325158509aa9

Public Version Date

September 22, 2022

Public Version Number

2

DI Record Publish Date

August 31, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-