FDA 510(k)
FDA class 1
Substantially Equivalent
🇹🇼 Taiwan
PATIENT EXAMINATION GLOVES (NON-STERILE VINYL)
K Number: K890851
·
Decision Apr 25, 1989
Classifications
1
FEI Numbers
131
Registration Numbers
131
Same Product Code
798
Applicant Total
2
Review Days
63
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Basic Information
- Device Name
- PATIENT EXAMINATION GLOVES (NON-STERILE VINYL)
- K Number
- K890851
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Daw Shin Industrial Co., Ltd.
- Date Received
- February 21, 1989
- Decision Date
- April 25, 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 Daw Shin Industrial Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K885346 | NON-STERILE VINYL GLOVES | Jan 18, 1989 | Substantially Equivalent |