FDA 510(k)
FDA class 1
Substantially Equivalent
🇻🇳 Vietnam
Disposable Powder Free Nitrile Examination Glove, White/ Blue/ Black/ Pink Color
K Number: K171422
·
Decision Jun 11, 2018
Classifications
1
FEI Numbers
380
Registration Numbers
380
Same Product Code
1171
Applicant Total
3
Review Days
392
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Basic Information
- Device Name
- Disposable Powder Free Nitrile Examination Glove, White/ Blue/ Black/ Pink Color
- K Number
- K171422
- Device Class
- FDA class 1
- Clearance Type
- Abbreviated
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Ever Global (Vietnam) Enterprise Corp
- Date Received
- May 15, 2017
- Decision Date
- June 11, 2018
- 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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