Medicom AssureTouch - Medicom AssureTouch Advanced Force - Nitrile - AMD Medicom Inc

Duns Number:256880576

Device Description: Medicom AssureTouch Advanced Force - Nitrile Medical Examination Gloves with Textured Fing Medicom AssureTouch Advanced Force - Nitrile Medical Examination Gloves with Textured Fingertips - Chemotherapy Tested - Powder Free - Non-Sterile - Blue - Sample 3 Pairs

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More Product Details

Catalog Number

1220-SP6

Brand Name

Medicom AssureTouch

Version/Model Number

1220-SP6

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

K091652,K091652

Product Code Details

Product Code

LZA

Product Code Name

Polymer Patient Examination Glove

Device Record Status

Public Device Record Key

5a02a9f6-9fec-4bf4-8f79-be0837150f52

Public Version Date

October 06, 2022

Public Version Number

1

DI Record Publish Date

September 28, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"AMD MEDICOM INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 84
2 A medical device with a moderate to high risk that requires special controls. 27
U Unclassified 2