FDA 510(k)
FDA class 1
Substantially Equivalent
🇲🇾 Malaysia
Nitrile Examination Gloves Powder Free Tested For Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black)
K Number: K230121
·
Decision May 15, 2023
Classifications
1
FEI Numbers
380
Registration Numbers
380
Same Product Code
1171
Applicant Total
8
Review Days
118
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Basic Information
- Device Name
- Nitrile Examination Gloves Powder Free Tested For Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black)
- K Number
- K230121
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Careglove Global Sdn. Bhd.
- Date Received
- January 17, 2023
- Decision Date
- May 15, 2023
- 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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Other Clearances by Careglove Global Sdn. Bhd.
| K Number | Device Name | ||
|---|---|---|---|
| K250578 | Nitrile Examination Gloves Powder Free Tested for Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black) | Apr 1, 2025 | Substantially Equivalent |
| K220859 | Powder Free Nitrile Examination Gloves, Colored (Green, Orange, Purple, White, & Black) | Sep 9, 2022 | Substantially Equivalent |
| K213993 | Powder Free Chloroprene Examination Glove Coloured (Blue, Green) | Aug 5, 2022 | Substantially Equivalent |
| K211666 | Powder Free Nitrile Examination Gloves, Blue Chemotest | Jan 9, 2022 | Substantially Equivalent |
| K190241 | Sterile Latex Surgical Glove, Powder Free | Dec 30, 2019 | Substantially Equivalent |
| K172015 | POWDER FREE NITRILE EXAMINATION GLOVES, BLUE (COLORED) | Sep 26, 2017 | Substantially Equivalent |
| K161833 | LATEX EXAMINATION GLOVE POWDER FREE | May 23, 2017 | Substantially Equivalent |