FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DENTAL POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM
K Number: K024102
·
Decision Dec 18, 2002
Classifications
1
FEI Numbers
151
Registration Numbers
151
Same Product Code
1953
Applicant Total
63
Review Days
6
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Basic Information
- Device Name
- DENTAL POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM
- K Number
- K024102
- Device Class
- FDA class 1
- Clearance Type
- Special
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Allegiance Healthcare Corp.
- Date Received
- December 12, 2002
- Decision Date
- December 18, 2002
- 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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Other Clearances by Allegiance Healthcare Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K023673 | AIRLIFE DEMAND NASAL CANNULA | May 2, 2003 | Substantially Equivalent |
| K023419 | TRILAMINATE DRAPES/TIBURON | Feb 11, 2003 | Substantially Equivalent |
| K024120 | MODIFICATION TO TEMNO BIOPSY NEEDLES | Jan 15, 2003 | Substantially Equivalent |
| K024292 | MODIFICATION TO POSITIVE TOUCH POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN AND CHEMOTHERAPY LABELING CLAIM | Jan 9, 2003 | Substantially Equivalent |
| K023425 | DRAPES WITH ABSORBENT REINFORCEMENT | Nov 6, 2002 | Substantially Equivalent |
| K022765 | NITRILE POWDER-FREE EXAMINATION GLOVES | Oct 11, 2002 | Substantially Equivalent |
| K023170 | NITRILE POWDER-FREE EXAMINATION GLOVES | Oct 9, 2002 | Substantially Equivalent |
| K023167 | BREATHABLE SURGICAL GOWN | Oct 2, 2002 | Substantially Equivalent |
| K012931 | GENESIS STERRAD COMPATIBLE REUSABLE STERILIZATION CONTAINER SYSTEM | Aug 20, 2002 | Substantially Equivalent |
| K020818 | POWDER-FREE LATEX EXAMINATION GLOVES WITH COLORANTS | Jul 5, 2002 | Substantially Equivalent |