FDA 510(k)
FDA class 1
Substantially Equivalent
🇨🇳 China
Powder Free Nitrile Examination Glove 2.8 Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, and Select Other Drugs
K Number: K233598
·
Decision Jan 26, 2024
Classifications
1
FEI Numbers
380
Registration Numbers
380
Same Product Code
1171
Applicant Total
4
Review Days
78
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Basic Information
- Device Name
- Powder Free Nitrile Examination Glove 2.8 Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, and Select Other Drugs
- K Number
- K233598
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Anhui Intco Medical Products Co., Ltd.
- Date Received
- November 9, 2023
- Decision Date
- January 26, 2024
- 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 Anhui Intco Medical Products Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K231365 | Nitrile Patient Examination Gloves with Hyaluronic Acid Blue Colored and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, aka Synguard C+ Nitrile Exam Gloves | Mar 1, 2024 | Substantially Equivalent |
| K191092 | Powder-Free Vinyl Patient Examination Gloves, Yellow Color | Jul 22, 2019 | Substantially Equivalent |
| K190095 | Powder-Free Clear Vinyl Patient Examination Gloves | Jun 20, 2019 | Substantially Equivalent |