FDA 510(k)
FDA class 1
Substantially Equivalent
🇹🇭 Thailand
ANSELL CONFORM GREEN EXAMINATION GLOVES
K Number: K897081
·
Decision Mar 26, 1990
Classifications
1
FEI Numbers
151
Registration Numbers
151
Same Product Code
795
Applicant Total
30
Review Days
97
Basic Information
- Device Name
- ANSELL CONFORM GREEN EXAMINATION GLOVES
- K Number
- K897081
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- ANSELL, INC.
- Date Received
- December 19, 1989
- Decision Date
- March 26, 1990
- 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.
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
Disposable Powder Free Vinyl Exam Glove, Black/Blue/Purple
FDA 510(k)
FDA Class 1
·General Hospital
Disposable Vinyl Examination Gloves
FDA 510(k)
FDA Class 1
·General Hospital
DISPOSABLE VINYL EXAMINATION GLOVES (Pink, Black, Blue)
FDA 510(k)
FDA Class 1
·General Hospital
Other Clearances by ANSELL, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K984392 | ANSELL CONDOMS | Jul 21, 1999 | Substantially Equivalent |
| K983518 | LIFESTYLES XTRA PLEASURE | Jul 6, 1999 | Substantially Equivalent |
| K940047 | SPERMICIDALLY LUBRICATED CONDOM | Dec 19, 1995 | Substantially Equivalent |
| K953379 | HYPOALLERGENIC POWDERED AMBIDEXTROUS COAGULATN DIPPED LATEX EXAMINATION GLOVE | Sep 27, 1995 | Substantially Equivalent |
| K945766 | HYPOALLERGENIC POWDERED AMBIDEXTROUS PATIENT EXAMINATION GLOVES | Aug 7, 1995 | Substantially Equivalent |
| K945767 | POWDER FREE, HYPOALLERGENIC AMBIDEXTROUS PATIENT EXAMINATION GLOVES | Mar 2, 1995 | Substantially Equivalent |
| K940045 | CONDOM | Jan 30, 1995 | Substantially Equivalent |
| K940046 | NON-LUBRICATED CONDOM | Jan 30, 1995 | Substantially Equivalent |
| K913766 | ANSELL NO POWDER AMBI PATIENT EXAMINATION GLOVES | Mar 11, 1993 | Substantially Equivalent |
| K914760 | LATEX EXAMINATION GLOVES | Jan 17, 1992 | Substantially Equivalent |