MocareHealth - Single-Use Nitrile Examination Gloves - Motex Healthcare(Anhui)Co.,Ltd.

Duns Number:560080502

Device Description: Single-Use Nitrile Examination Gloves

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More Product Details

Catalog Number

-

Brand Name

MocareHealth

Version/Model Number

7235XL

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)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K030207,K030207

Product Code Details

Product Code

LZA

Product Code Name

Polymer Patient Examination Glove

Device Record Status

Public Device Record Key

97f79664-0907-4c76-9900-ebe6a54d1fee

Public Version Date

September 01, 2021

Public Version Number

1

DI Record Publish Date

August 24, 2021

Additional Identifiers

Package DI Number

36971384150054

Quantity per Package

10

Contains DI Package

26971384150057

Package Discontinue Date

August 24, 2026

Package Status

In Commercial Distribution

Package Type

CASE

"MOTEX HEALTHCARE(ANHUI)CO.,LTD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 15