SemperShield EC Nitrile Exam Glove - SemperShield EC Nitrile Exam Glove, size XL - SEMPERMED USA, INC.

Duns Number:004072158

Device Description: SemperShield EC Nitrile Exam Glove, size XL

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More Product Details

Catalog Number

SSEC105

Brand Name

SemperShield EC Nitrile Exam Glove

Version/Model Number

SSEC105

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

OPJ

Product Code Name

Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs

Device Record Status

Public Device Record Key

96c99f0a-661f-4954-a524-48d4570f575d

Public Version Date

June 19, 2020

Public Version Number

2

DI Record Publish Date

March 01, 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