FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TEKMEDIC POWDERED SINGLE-USE LATEX PATIENT EXAMINATION GLOVES WITH PROTEIN & POWDER LABEL CLAIM CONTAINS 70MGM OR LESS O
K Number: K000555
·
Decision Apr 12, 2000
Classifications
1
FEI Numbers
169
Registration Numbers
169
Same Product Code
1953
Applicant Total
11
Review Days
54
Basic Information
- Device Name
- TEKMEDIC POWDERED SINGLE-USE LATEX PATIENT EXAMINATION GLOVES WITH PROTEIN & POWDER LABEL CLAIM CONTAINS 70MGM OR LESS O
- K Number
- K000555
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- TEKMEDIC (M) SDN BHD
- Date Received
- February 18, 2000
- Decision Date
- April 12, 2000
- 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 TEKMEDIC (M) SDN BHD
| K Number | Device Name | ||
|---|---|---|---|
| K121592 | POWDER FREE BLUE NITRILE EXAMINATION GLOVE TESTED WITH CHEMOTHERAPY DRUGS | Jan 18, 2013 | Substantially Equivalent |
| K121594 | COLORED POWDER FREE LATEX EXAMINATION GLOVE (WHITE AND BLUE) | Oct 25, 2012 | Substantially Equivalent |
| K121591 | FLAVORED POWDER FREE AND POLYMER COATED EXAMINATION GLOVE (VANLLA, GRAPE AND STRAWBERRY) | Oct 11, 2012 | Substantially Equivalent |
| K121192 | NITRILE EXAMINATION GLOVES (WHITE, BLUE AND BLACK) | Aug 3, 2012 | Substantially Equivalent |
| K100694 | COLORED POWDER FREE AND POLYMER COATED EXAMINATION GLOVE (BLUE, BLACK AND PINK) WITH A PROTEIN CLAIM OF LESS THAN | Jun 25, 2010 | Substantially Equivalent |
| K013317 | TEKMEDIC POWDER-FREE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) | Dec 17, 2001 | Substantially Equivalent |
| K994250 | TEKMEDIC POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) | Feb 7, 2000 | Substantially Equivalent |
| K971949 | POWDER-FREE PATIENT EXAMINATION GLOVES | Jul 28, 1997 | Substantially Equivalent |
| K930602 | LATEX EXAMINATION GLOVES, POWDER FREE | Sep 29, 1993 | Substantially Equivalent |
| K892094 | PATIENT EXAMINATION GLOVES (LATEX) | May 31, 1989 | Substantially Equivalent |