BLOSSOM - VINYL EXAMINATION GLOVES POWDER FREE (SMALL) - Mexpo International Inc.

Duns Number:779982974

Device Description: VINYL EXAMINATION GLOVES POWDER FREE (SMALL)

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More Product Details

Catalog Number

BM 9226-V-PF

Brand Name

BLOSSOM

Version/Model Number

BM 9226-V-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"

-

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

LYZ

Product Code Name

Vinyl Patient Examination Glove

Device Record Status

Public Device Record Key

42cd12d8-53df-4916-ab45-f1bce589b9b9

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