DEVICE: TOUCH Chemo Tested Nitrile Exam Glove (00850014448219)
Device Identifier (DI) Information
TOUCH Chemo Tested Nitrile Exam Glove
PRG-CTN-M
In Commercial Distribution
LABOTEK GROUP CORP
PRG-CTN-M
In Commercial Distribution
LABOTEK GROUP CORP
TOUCH Nitrile Examination Glove, Chemotherapy tested, Size Medium
Device Characteristics
Labeling does not contain MRI Safety Information | |
Yes | |
No | |
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? |
---|---|---|---|---|
56286 | Nitrile examination/treatment glove, non-powdered, non-antimicrobial |
A device made of nitrile 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 powder and it does not include antimicrobial agents/materials. 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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LZA | Polymer Patient Examination Glove |
LZC | Medical Glove, Specialty |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K170136 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 41 and 100 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
ccd9b599-5b9a-4fc0-83eb-c6928d0485c8
March 26, 2024
1
March 18, 2024
March 26, 2024
1
March 18, 2024
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
00850014448226 | 200 | 00850014448219 | In Commercial Distribution | Box | |
10850014448223 | 10 | 00850014448226 | In Commercial Distribution | Case |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
10850014448216
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
7877851555
e.colon@labotekgroup.com
e.colon@labotekgroup.com