KS-CARE POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50UG OR LESS)— 510(k) K093375
Substantially EquivalentKoon Seng Sdn Bhd
FDA 510(k) clearance K093375 for KS-CARE POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50UG OR LESS), Substantially Equivalent on 2009-12-02. Applicant: Koon Seng Sdn Bhd. Device class: 1.
Clearance details
- Applicant
- Koon Seng Sdn Bhd
- 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
- Traditional
- Location
- Great Neck, NY, US
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