FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
POLY (VINYL) EXAM GLOVE, POWDERED
K Number: K971316
·
Decision Aug 27, 1997
Classifications
1
FEI Numbers
131
Registration Numbers
131
Same Product Code
798
Applicant Total
8
Review Days
140
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Basic Information
- Device Name
- POLY (VINYL) EXAM GLOVE, POWDERED
- K Number
- K971316
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Copioumed Intl., Inc.
- Date Received
- April 9, 1997
- Decision Date
- August 27, 1997
- 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 Copioumed Intl., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K030927 | POWDERED VINYL EXAM GLOVES, WHITE | Apr 17, 2003 | Substantially Equivalent |
| K021961 | POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: WHITE | Jul 2, 2002 | Substantially Equivalent |
| K021743 | (MULTIPLE LABELS) POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: YELLOW | Jun 10, 2002 | Substantially Equivalent |
| K972624 | POLY (VINYL) EXAM GLOVE, POWDER-FREE | Nov 6, 1997 | Substantially Equivalent |
| K965237 | NURSES BOUFFANT CAP | Aug 27, 1997 | Substantially Equivalent |
| K960999 | ISOLATION GOWN | Dec 30, 1996 | Substantially Equivalent |
| K961342 | SHOE COVER, NON-STERILE | Dec 30, 1996 | Substantially Equivalent |