FDA 510(k)
FDA class 1
Substantially Equivalent
🇨🇳 China
DISPOSABLE VINYL EXAMINATION GLOVES (Pink, Black, Blue)
K Number: K222442
·
Decision Sep 28, 2022
Classifications
1
FEI Numbers
151
Registration Numbers
151
Same Product Code
795
Applicant Total
2
Review Days
47
Basic Information
- Device Name
- DISPOSABLE VINYL EXAMINATION GLOVES (Pink, Black, Blue)
- K Number
- K222442
- 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 Bytech Medical Supplies Co., Ltd.
- Date Received
- August 12, 2022
- Decision Date
- September 28, 2022
- 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
Other 510(k) clearances with the same product code (LYZ), ordered by most recent decision date.
Disposable Vinyl Examination Gloves
FDA 510(k)
FDA Class 1
·General Hospital
Vinyl examination gloves
FDA 510(k)
FDA Class 1
·General Hospital
Disposable Powder Free Vinyl Examination Gloves, Beige/Clear
FDA 510(k)
FDA Class 1
·General Hospital
Disposable Powder Free Vinyl Exam Glove, Black/Blue/Purple
FDA 510(k)
FDA Class 1
·General Hospital
Disposable Vinyl Examination Gloves
FDA 510(k)
FDA Class 1
·General Hospital
Disposable, vinyl examination gloves, Yellow
FDA 510(k)
FDA Class 1
·General Hospital
Other Clearances by Anhui Bytech Medical Supplies Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K201504 | Single-use medical poly (vinyl chloride) examination glove | May 10, 2021 | Substantially Equivalent |