Catalog Number

-

Brand Name

ATOMO

Version/Model Number

AA0071

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"

-

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

K141303,K141303,K141303

Product Code

LZA

Product Code Name

Polymer Patient Examination Glove

Public Device Record Key

165f2776-8250-4443-8b00-1ce22518b2ee

Public Version Date

July 27, 2022

Public Version Number

1

DI Record Publish Date

July 19, 2022

Package DI Number

D883AA00713

Quantity per Package

10

Contains DI Package

D883AA00711

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton