J2-100 - BLUE, NITRILE MEDICAL EXAMINATION GLOVES, - J2 Medical Supply Inc.

Duns Number:117257038

Device Description: BLUE, NITRILE MEDICAL EXAMINATION GLOVES, LATEX-FREE, POWDER-FREE, ASTM D6319

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More Product Details

Catalog Number

-

Brand Name

J2-100

Version/Model Number

JVNGWZ4LC

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

K192333,K192333

Product Code Details

Product Code

LZA

Product Code Name

Polymer Patient Examination Glove

Device Record Status

Public Device Record Key

08548627-3a1e-4bfb-abc7-8e82b3ad6c8f

Public Version Date

June 14, 2021

Public Version Number

1

DI Record Publish Date

June 04, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"J2 MEDICAL SUPPLY INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 4