DEVICE: Medicom AssureTouch Shield (20686864059510)
Device Identifier (DI) Information
Medicom AssureTouch Shield
9994-SP6
In Commercial Distribution
9994-SP6
AMD Medicom Inc
9994-SP6
In Commercial Distribution
9994-SP6
AMD Medicom Inc
Medicom AssureTouch Shield - Vinyl Medical Examination Gloves - Powder Free - Non-Sterile - Clear - Sample Pack
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
Yes | |
No | |
Yes | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
47176 | Vinyl examination/treatment glove, non-powdered |
A non-sterile device made of vinyl intended as a protective barrier when worn on the hands of healthcare providers during patient examination/treatment or for other sanitary purposes; its inner surface is not covered with talcum powder and it does not have antimicrobial features. The device is used mainly as a two-way barrier to protect patient/staff against contaminants and risk of allergy to latex. It will have appropriate characteristics regarding tactility and comfort of use, and should provide appropriate physical properties (e.g., tensile strength, resistance to puncture, elasticity), and uniformity of dimensions (i.e., sizing consistency). This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LYZ | Vinyl patient examination glove |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K182115 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Cool dry place - Avoid excessive heat (40°C, 104°F) |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
555e5e32-261f-4884-9af7-d48670d03607
November 09, 2022
2
August 01, 2022
November 09, 2022
2
August 01, 2022
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
00686864059516
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(514)636-6262
2309
mkansou@medicom.ca +1(514)636-6262
mdasilva@medicom.ca
mkansou@medicom.ca +1(514)636-6262
mdasilva@medicom.ca