FDA 510(k)
FDA class 1
Substantially Equivalent
🇹🇼 Taiwan
PATIENT EXAMINATION GLOVES (VINYL)
K Number: K891336
·
Decision Sep 13, 1989
Classifications
1
FEI Numbers
131
Registration Numbers
131
Same Product Code
798
Applicant Total
4
Review Days
187
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Basic Information
- Device Name
- PATIENT EXAMINATION GLOVES (VINYL)
- K Number
- K891336
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Kaohsiung Brothers Products Corp.
- Date Received
- March 10, 1989
- Decision Date
- September 13, 1989
- 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 |
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Other Clearances by Kaohsiung Brothers Products Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K030200 | POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, WHITE | Mar 20, 2003 | Substantially Equivalent |
| K003197 | VINYL, POWDER-FREE, PATIENT EXAMINATION GLOVES, YELLOW | Nov 22, 2000 | Substantially Equivalent |
| K000058 | BROTHERS POWDER-FREE VINYL EXAMINATION GLOVES | Mar 10, 2000 | Substantially Equivalent |