FDA 510(k)
FDA class 1
Substantially Equivalent
🇨🇳 China
Nitrile Exam Glove, Tested For Use With Chemotherapy Drugs And Fentanyl
K Number: K231029
·
Decision Oct 30, 2023
Classifications
1
FEI Numbers
380
Registration Numbers
380
Same Product Code
1171
Applicant Total
5
Review Days
202
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Basic Information
- Device Name
- Nitrile Exam Glove, Tested For Use With Chemotherapy Drugs And Fentanyl
- K Number
- K231029
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Zhonghong Pulin Medical Products Co., Ltd.
- Date Received
- April 11, 2023
- Decision Date
- October 30, 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 Zhonghong Pulin Medical Products Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K230662 | Nitrile Exam Glove, Extended cuff, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, And Select Other Drugs | Oct 26, 2023 | Substantially Equivalent |
| K210460 | NitriTec Vinyl Glove Powder Free Blue | May 17, 2021 | Substantially Equivalent |
| K171873 | Powder Free Nitrile Patient Examination Glove, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs | Nov 15, 2017 | Substantially Equivalent |
| K152712 | Nitrile Powder Free Patient Examination Gloves, Blue Color | Mar 9, 2016 | Substantially Equivalent |