FDA 510(k)
FDA class 1
Substantially Equivalent
🇹🇼 Taiwan
PACER PLUS SYNTHETIC MEDICAL VINYL PATIENT EXAMINATION GLOVE POWDER FREE
K Number: K963710
·
Decision Oct 24, 1996
Classifications
1
FEI Numbers
131
Registration Numbers
131
Same Product Code
798
Applicant Total
8
Review Days
38
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Basic Information
- Device Name
- PACER PLUS SYNTHETIC MEDICAL VINYL PATIENT EXAMINATION GLOVE POWDER FREE
- K Number
- K963710
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Canopus Medical Supply Co., Ltd.
- Date Received
- September 16, 1996
- Decision Date
- October 24, 1996
- 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 Canopus Medical Supply Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K120798 | DISPOSABLE POWER FREE VINYL EXAM GLOVE, PINK COLOR | May 14, 2012 | Substantially Equivalent |
| K120746 | DISPOSABLE POWDER FREE VINYL EXAM GLOVES | Apr 27, 2012 | Substantially Equivalent |
| K023452 | OPUS-E DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH NOPAL & VITAMIN E | Nov 20, 2003 | Substantially Equivalent |
| K023728 | DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR | Jan 7, 2003 | Substantially Equivalent |
| K022368 | DISPOSABLE POWDER FREE VINYL EXAM GLOVES, WITH VITAMIN E | Sep 5, 2002 | Substantially Equivalent |
| K013753 | DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR | Dec 10, 2001 | Substantially Equivalent |
| K941357 | VINYL EXAMINATION GLOVE, POWDER FREE | Apr 29, 1994 | Substantially Equivalent |