Honeywell Performance Exam Glove - Honeywell Performance Exam Glove, Chemo, US, - Honeywell Safety Products Usa, Inc.

Duns Number:080388984

Device Description: Honeywell Performance Exam Glove, Chemo, US, SKYBL, Large

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More Product Details

Catalog Number

-

Brand Name

Honeywell Performance Exam Glove

Version/Model Number

4580601-L

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

K203236

Product Code Details

Product Code

LZA

Product Code Name

Polymer Patient Examination Glove

Device Record Status

Public Device Record Key

108e974e-52e9-4a87-a8a5-0cd185e57c9a

Public Version Date

March 07, 2022

Public Version Number

1

DI Record Publish Date

February 25, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HONEYWELL SAFETY PRODUCTS USA, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2