Catalog Number

9003047

Brand Name

CUSTOMED

Version/Model Number

712057693047

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)

Yes

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

K010198,K010198,K010198,K010198

Product Code

KGO

Product Code Name

Surgeon'S Gloves

Public Device Record Key

27f55221-4dac-431b-af43-a38dd2775868

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

M20890030471

Quantity per Package

50

Contains DI Package

M20890030477

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

50PR/BOX