FDA 510(k)
FDA class 1
Substantially Equivalent
🇲🇾 Malaysia
Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims
K Number: K213437
·
Decision Apr 11, 2022
Classifications
1
FEI Numbers
380
Registration Numbers
380
Same Product Code
1171
Applicant Total
15
Review Days
171
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Basic Information
- Device Name
- Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims
- K Number
- K213437
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Central Medicare Sdn Bhd
- Date Received
- October 22, 2021
- Decision Date
- April 11, 2022
- 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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FDA 510(k)
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Other Clearances by Central Medicare Sdn Bhd
| K Number | Device Name | ||
|---|---|---|---|
| K230681 | Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl | Oct 2, 2023 | Substantially Equivalent |
| K223752 | Black Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Chloroquine, Cyclosporin A, Retrovir, Gastric Acid and Fentanyl | Jul 24, 2023 | Substantially Equivalent |
| K230875 | Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims | Jul 20, 2023 | Substantially Equivalent |
| K230564 | Green Non Sterile Powder Free Nitrile Examination Gloves | May 23, 2023 | Substantially Equivalent |
| K211022 | Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims. | Dec 22, 2021 | Substantially Equivalent |
| K203036 | Non Sterile Powder Free Polyurethane Examination Gloves (Blue and Black colors) | May 7, 2021 | Substantially Equivalent |
| K183149 | Blue Non-Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Low Dermatitis and Fentanyl Permeation Resistance Claim | Jul 4, 2019 | Substantially Equivalent |
| K173942 | Blue Non Sterile powder free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs | Mar 5, 2018 | Substantially Equivalent |
| K172642 | Orange Non Sterile Powder Free Nitrile Examination Gloves | Nov 28, 2017 | Substantially Equivalent |
| K172525 | Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs | Nov 13, 2017 | Substantially Equivalent |