NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES WITH POLYMER COATING AND PROTEIN CLAIM (50 MICROGRAMS OR LESS)— 510(k) K081907
Substantially EquivalentSiam Sempermed Corp., Ltd.
FDA 510(k) clearance K081907 for NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES WITH POLYMER COATING AND PROTEIN CLAIM (50 MICROGRAMS OR LESS), Substantially Equivalent on 2008-09-03. Applicant: Siam Sempermed Corp., Ltd.. Device class: 1.
Clearance details
- Applicant
- Siam Sempermed Corp., Ltd.
- Product code
- Code LYY
- Device class
- Class 1
- Regulation
- 21 CFR 880.6250
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Clearwater, FL, US
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