FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BALDUR BRAND VINYL POWDERED EXAMINATION GLOVES, SUN FLOWER GLOVES CO., LTD
K Number: K022336
·
Decision Oct 11, 2002
Classifications
1
FEI Numbers
131
Registration Numbers
131
Same Product Code
798
Applicant Total
3
Review Days
85
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- BALDUR BRAND VINYL POWDERED EXAMINATION GLOVES, SUN FLOWER GLOVES CO., LTD
- K Number
- K022336
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Tangshan Zhonghong Pulin Group Co., Ltd.
- Date Received
- July 18, 2002
- Decision Date
- October 11, 2002
- 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.
Powder Free Synthetic Vinyl Exam Gloves (Blue, Black)
FDA 510(k)
FDA Class 1
·General Hospital
Disposable Vinyl Examination Gloves
FDA 510(k)
FDA Class 1
·General Hospital
Powder-Free Vinyl Exam Gloves, clear
FDA 510(k)
FDA Class 1
·General Hospital
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