FDA 510(k)
FDA class 1
Substantially Equivalent
🇨🇳 China
Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile)
K Number: K211667
·
Decision Sep 23, 2021
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
3
Applicant Total
3
Review Days
114
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Basic Information
- Device Name
- Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile)
- K Number
- K211667
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.3280
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Changzhou Universal Medical Equipment Co., Ltd.
- Date Received
- June 1, 2021
- Decision Date
- September 23, 2021
- Product Code
- LAZ
- Advisory Committee
- Clinical Toxicology
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| LAZ | N-Acetylprocainamide Control Materials | FDA class 1 | Clinical Toxicology |
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