nitrylex classic blue - Nitrile examination/treatment glove, - MERCATOR MEDICAL (THAILAND) LIMITED

Duns Number:671647476

Device Description: Nitrile examination/treatment glove, non-powdered, non-antimicrobial Size: XL Pack: 10 in Nitrile examination/treatment glove, non-powdered, non-antimicrobial Size: XL Pack: 10 inner boxes/ carton

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More Product Details

Catalog Number

-

Brand Name

nitrylex classic blue

Version/Model Number

RD30019905_0001

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

K172930

Product Code Details

Product Code

LZA

Product Code Name

Polymer Patient Examination Glove

Device Record Status

Public Device Record Key

9b7cd767-fd3f-49d4-9cf0-3d9c43096f8f

Public Version Date

February 17, 2021

Public Version Number

1

DI Record Publish Date

February 09, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MERCATOR MEDICAL (THAILAND) LIMITED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 20