Safe .R World - Nitrile examination/treatment glove, - Safe.R World Corporation

Duns Number:048020664

Device Description: Nitrile examination/treatment glove, non-powdered, non-antimicrobial, single use, 100 coun Nitrile examination/treatment glove, non-powdered, non-antimicrobial, single use, 100 count

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More Product Details

Catalog Number

NGPF32MBX501

Brand Name

Safe .R World

Version/Model Number

3.2 g. Medium

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"

-

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

K071910,K071910,K071910

Product Code Details

Product Code

LZA

Product Code Name

Polymer Patient Examination Glove

Device Record Status

Public Device Record Key

00af9b47-47ce-4453-8eec-162d1907342d

Public Version Date

August 17, 2022

Public Version Number

1

DI Record Publish Date

August 09, 2022

Additional Identifiers

Package DI Number

00860009069992

Quantity per Package

10

Contains DI Package

00860008943200

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton

"SAFE.R WORLD CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2