Catalog Number

TC21NL

Brand Name

TEC GLOVES

Version/Model Number

Large

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

K152720,K152720

Product Code

LZA

Product Code Name

Polymer Patient Examination Glove

Public Device Record Key

59063b03-026d-4ea7-8769-f8c9223e3a42

Public Version Date

October 17, 2022

Public Version Number

1

DI Record Publish Date

October 07, 2022

Package DI Number

00860009233560

Quantity per Package

1000

Contains DI Package

00860009233522

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case