ROYAL IMPERIAL POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR— 510(k) K012714
Substantially EquivalentKoon Seng Sdn Bhd
FDA 510(k) clearance K012714 for ROYAL IMPERIAL POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR, Substantially Equivalent on 2001-10-31. 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
- Muar, Johor, MY
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Data sourced from openFDA. This site is unofficial and independent of the FDA.