FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NON-STERILE POWDER-FREE BLUE LATEX EXAMINATION GLOVES, WITH AND WITHOUT BUBBLEGUM SCENTING & A PROTEIN LABELING CLAIM (5
K Number: K011377
·
Decision Jun 7, 2001
Classifications
1
FEI Numbers
169
Registration Numbers
169
Same Product Code
1953
Applicant Total
31
Review Days
34
Basic Information
- Device Name
- NON-STERILE POWDER-FREE BLUE LATEX EXAMINATION GLOVES, WITH AND WITHOUT BUBBLEGUM SCENTING & A PROTEIN LABELING CLAIM (5
- K Number
- K011377
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- SGMP CO., LTD.
- Date Received
- May 4, 2001
- Decision Date
- June 7, 2001
- 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 SGMP CO., LTD.
| K Number | Device Name | ||
|---|---|---|---|
| K112693 | NON-STERILE, POWER FREE YELLOW LATEX EXAMINATION GLOVES | Sep 12, 2012 | Substantially Equivalent |
| K101822 | NON-STERILE POWDER-FREE BLUE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS | Nov 19, 2010 | Substantially Equivalent |
| K101646 | NON-STERILE, POWDER FREE BLACK NITRILE EXAMINATION GLOVES WITH CHERRY FLAVOR | Sep 8, 2010 | Substantially Equivalent |
| K072403 | NON-STERILE, POWDERED, PINK LATEX EXAMINATION GLOVES WITH CHERRY FLAVOUR AND PROTEIN LABELING CLAIMS (200 UG OR LESS) | Mar 27, 2008 | Substantially Equivalent |
| K072400 | NON-STERILE, POWDER-FREE, BLACK NITRILE EXAMINATION GLOVES | Mar 27, 2008 | Substantially Equivalent |
| K072406 | NON-STERILE, POWDER FREE, PINK LATEX EXAMINATION GLOVES WITH CHERRY FLAVOUR AND PROTEIN LABELING CLAIMS (50 UG OR LESS) | Mar 21, 2008 | Substantially Equivalent |
| K071060 | NON-STERILE, LATEX POWDER FREE PATIENT EXAMINATION GLOVES (MULTICOLORED WITH XYLITOL AND CALCIUM CARBONATE) | Jul 26, 2007 | Substantially Equivalent |
| K052016 | NON-STERILE POWDER FREE MULTICOLOR - RED, BLUE, PURPLE AND YELLOW LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING | Sep 1, 2005 | Substantially Equivalent |
| K042879 | NON-STERILE POWDER-FREE BLUE NITRILE EXAMINATION GLOVES, WITH VANILLA SCENTING | Jan 13, 2005 | Substantially Equivalent |
| K023537 | NON-STERILE POWDER FREE GREEN LATEX PATIENT EXAM GLOVES WITH SURFACE COATING & PROTEIN LABELING CLAIM (<50UG/DM2) | Nov 20, 2003 | Substantially Equivalent |