FDA 510(k)
FDA class 1
Substantially Equivalent
🇻🇳 Vietnam
Disposable Powder Free Vinyl Exam Glove, Clear/Yellow
K Number: K172357
·
Decision Dec 29, 2017
Classifications
1
FEI Numbers
131
Registration Numbers
131
Same Product Code
798
Applicant Total
4
Review Days
148
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Basic Information
- Device Name
- Disposable Powder Free Vinyl Exam Glove, Clear/Yellow
- K Number
- K172357
- 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 Growth (Vietnam) Co. , Ltd.
- Date Received
- August 3, 2017
- Decision Date
- December 29, 2017
- Product Code
- LYZ
- 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 |
|---|---|---|---|
| LYZ | Vinyl Patient Examination Glove | FDA class 1 | General Hospital |
Similar 510(k) Clearances
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Other Clearances by Ever Growth (Vietnam) Co. , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K190942 | Disposable Powder Free Nitrile Examination Glove, Pink/Black Color | Jan 7, 2020 | Substantially Equivalent |
| K190736 | Disposable Powder Free Nitrile Examination Glove,Blue Color, Tested For Use With Chemotherapy Drugs | Dec 23, 2019 | Substantially Equivalent |
| K190860 | Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, White color, Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, Orange color | Dec 23, 2019 | Substantially Equivalent |