FDA 510(k)
FDA class 1
Substantially Equivalent
🇻🇳 Vietnam
Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate and Xylazine
K Number: K244034
·
Decision Feb 6, 2025
Classifications
1
FEI Numbers
380
Registration Numbers
380
Same Product Code
1171
Applicant Total
5
Review Days
38
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Basic Information
- Device Name
- Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate and Xylazine
- K Number
- K244034
- Device Class
- FDA class 1
- Clearance Type
- Special
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ever Global (Vietnam) Enterprise Corporation
- Date Received
- December 30, 2024
- Decision Date
- February 6, 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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Other Clearances by Ever Global (Vietnam) Enterprise Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K252244 | Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, Xylazine, Gastric acid, Fentanyl in Gastric acid and Xylazine in Gastric acid | Aug 21, 2025 | Substantially Equivalent |
| K221980 | Disposable Powder Free Vinyl Examination Gloves, Beige/Clear | Feb 6, 2023 | Substantially Equivalent |
| K220992 | Disposable Powder Free Vinyl Exam Glove, Black/Blue/Purple | Oct 19, 2022 | Substantially Equivalent |
| K190403 | Disposable Powder Free Nitrile Examination Glove, White, Tested for Use With Chemotherapy Drugs, Disposable Powder Free Nitrile Examination Glove, Blue, Tested for Use With Chemotherapy Drugs | Sep 6, 2019 | Substantially Equivalent |