SemperShield Black Nitrile Exam Glove - SemperShield Black Nitrile Exam Glove, size XS - SEMPERMED USA, INC.

Duns Number:004072158

Device Description: SemperShield Black Nitrile Exam Glove, size XS

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More Product Details

Catalog Number

SSBN101

Brand Name

SemperShield Black Nitrile Exam Glove

Version/Model Number

SSBN101

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

-

Product Code Details

Product Code

LZA

Product Code Name

Polymer Patient Examination Glove

Device Record Status

Public Device Record Key

bd24109f-0380-474c-bd56-864d161b5b9e

Public Version Date

August 10, 2020

Public Version Number

1

DI Record Publish Date

July 31, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SEMPERMED USA, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 54