ROYAL IMPERIAL POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)— 510(k) K013537
Substantially EquivalentKoon Seng Sdn Bhd
FDA 510(k) clearance K013537 for ROYAL IMPERIAL POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS), Substantially Equivalent on 2001-12-07. 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
Recent devices under product code LYY
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Data sourced from openFDA. This site is unofficial and independent of the FDA.