BLOSSOM - CHLOROPRENE EXAMINATION GLOVES POWDER FREE - Mexpo International Inc.

Duns Number:779982974

Device Description: CHLOROPRENE EXAMINATION GLOVES POWDER FREE AVOCADO GREEN (X-SMALL)

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More Product Details

Catalog Number

BM 97325-CHL-LG-PF

Brand Name

BLOSSOM

Version/Model Number

BM 97325-CHL-LG-PF

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

-

Product Code Details

Product Code

OPC

Product Code Name

Powder-Free Polychloroprene Patient Examination Glove

Device Record Status

Public Device Record Key

3273cab9-801a-40e3-a805-25359d0f467f

Public Version Date

March 03, 2022

Public Version Number

1

DI Record Publish Date

February 23, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEXPO INTERNATIONAL INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 177
2 A medical device with a moderate to high risk that requires special controls. 13