FDA 510(k)
FDA class 1
Substantially Equivalent
🇹🇭 Thailand
Powder Free Nitrile Patient Examination Glove, Blue colored, Non-sterile Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Patient Examination Glove, Black colored, Non-sterile Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
K Number: K251141
·
Decision Nov 17, 2025
Classifications
1
FEI Numbers
380
Registration Numbers
380
Same Product Code
1171
Applicant Total
7
Review Days
217
Basic Information
- Device Name
- Powder Free Nitrile Patient Examination Glove, Blue colored, Non-sterile Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Patient Examination Glove, Black colored, Non-sterile Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
- K Number
- K251141
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Mercator Medical (Thailand), Ltd.
- Date Received
- April 14, 2025
- Decision Date
- November 17, 2025
- Product Code
- LZA
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LZA | Polymer Patient Examination Glove | FDA class 1 | General Hospital |
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Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid; Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Blue), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid
FDA 510(k)
FDA Class 1
·General Hospital
Other Clearances by Mercator Medical (Thailand), Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K213548 | Nitrylex Classic Powder Free Nitrile Blue Examination Gloves Tested for Use with Chemotherapy | Feb 21, 2022 | Substantially Equivalent |
| K200967 | mCare(R) Powder Free Nitrile Orange Examination Gloves | Jun 6, 2020 | Substantially Equivalent |
| K192444 | mCare® Powder Free Nitrile Black Examination Glove | Dec 31, 2019 | Substantially Equivalent |
| K190876 | mCare®Powder-free Nitrile Blue Examination Gloves with Chemotherapy Drugs Labeling Claimed | Dec 2, 2019 | Substantially Equivalent |
| K172930 | mCare Powder-free Blue Nitrile Examination Gloves | Apr 13, 2018 | Substantially Equivalent |
| K141042 | MCARE PF POWDER FREE LATEX EXAMINATION HIGH RISK GLOVES | Mar 19, 2015 | Substantially Equivalent |