FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NON-STERILE EXAM GLOVES
K Number: K892325
·
Decision May 31, 1989
Classifications
1
FEI Numbers
151
Registration Numbers
151
Same Product Code
1953
Applicant Total
30
Review Days
58
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Basic Information
- Device Name
- NON-STERILE EXAM GLOVES
- K Number
- K892325
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Ansell, Inc.
- Date Received
- April 3, 1989
- Decision Date
- May 31, 1989
- Product Code
- LYY
- 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 |
|---|---|---|---|
| LYY | Latex Patient Examination Glove | FDA class 1 | General Hospital |
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Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeling Claim (Contains 50 ug per dm2 of glove or less of Total Water Extractable Protein)
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Non Sterile Powder Free Latex Examination Glove
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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 |