huayuan - Nitrile examination gloves,blue,M - Dong Tai City Huayi Gloves Co.,Ltd

Duns Number:542981202

Device Description: Nitrile examination gloves,blue,M

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More Product Details

Catalog Number

-

Brand Name

huayuan

Version/Model Number

Nitrile

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

August 19, 2026

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)

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

K131823

Product Code Details

Product Code

LZA

Product Code Name

Polymer Patient Examination Glove

Device Record Status

Public Device Record Key

eeff226c-d06e-409d-9cc9-35e38fed26af

Public Version Date

August 27, 2021

Public Version Number

1

DI Record Publish Date

August 19, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DONG TAI CITY HUAYI GLOVES CO.,LTD" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 24