HEPRO.US Sterile Latex Surgical Gloves Size X-Large 8.5" - Surgical Gloves-Non-powder Sterilized by Gamma - HEPRO.US INC.

Duns Number:080061451

Device Description: Surgical Gloves-Non-powder Sterilized by Gamma Radiation, Sterile Until 50 pairs 1- Box

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More Product Details

Catalog Number

-

Brand Name

HEPRO.US Sterile Latex Surgical Gloves Size X-Large 8.5"

Version/Model Number

BX - Surgical Latex Gloves 8.5"

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Safe

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

KGO

Product Code Name

Surgeon'S Gloves

Device Record Status

Public Device Record Key

828538da-d46e-485a-ac1b-6c17d371f785

Public Version Date

June 19, 2020

Public Version Number

3

DI Record Publish Date

June 21, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HEPRO.US INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2
2 A medical device with a moderate to high risk that requires special controls. 20