FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES WITH POLYMER COATING AND PROTEIN CLAIM (50 MICROGRAMS OR LESS)
K Number: K081907
·
Decision Sep 3, 2008
Classifications
1
FEI Numbers
151
Registration Numbers
151
Same Product Code
1953
Applicant Total
37
Review Days
62
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Basic Information
- Device Name
- NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES WITH POLYMER COATING AND PROTEIN CLAIM (50 MICROGRAMS OR LESS)
- K Number
- K081907
- Device Class
- FDA class 1
- Clearance Type
- Abbreviated
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Siam Sempermed Corp., Ltd.
- Date Received
- July 3, 2008
- Decision Date
- September 3, 2008
- 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 Siam Sempermed Corp., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K142685 | NITRILE EXAMINATION GLOVES WITH ALOE & VITAMIN E, POWDER- FREE | Feb 11, 2015 | Substantially Equivalent |
| K121549 | NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE | Dec 27, 2012 | Substantially Equivalent |
| K122363 | NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, BLUE | Sep 10, 2012 | Substantially Equivalent |
| K100907 | NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES AND PROTEIN CLAIM (50 MICROGRAMS OR LESS) MODEL: WHITE: X-SMALL, SMALL | Jul 9, 2010 | Substantially Equivalent |
| K082957 | NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE COLOR, POLYMER COATED, TESTED WITH CHEMOTHERAPY DRUGS | May 29, 2009 | Substantially Equivalent |
| K083755 | NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, LAVENDER BLUE COLOR, POLYMER COATED, TEXTED WITH CHEMOTHERAPY DRUGS | Mar 5, 2009 | Substantially Equivalent |
| K081911 | NON-STERILE, POWDERED NITRILE EXAMINATION GLOVE, BLUE | Jan 15, 2009 | Substantially Equivalent |
| K081910 | NON-STERILE, POWDERED LATEX EXAMINATION GLOVE | Sep 17, 2008 | Substantially Equivalent |
| K080520 | NON STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE, POLYMER COATING WITH CHEMOTHERAPY CLAIM | Apr 30, 2008 | Substantially Equivalent |
| K070639 | NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE WITH POLYMER COATING | Jun 15, 2007 | Substantially Equivalent |