POWDER FREE LATEX PATIENT EXAMINATION GLOVE, WITH PROTEIN CONTENT LABELING CLAIM— 510(k) K112612
Substantially EquivalentTop Calibre Sdn Bhd
FDA 510(k) clearance K112612 for POWDER FREE LATEX PATIENT EXAMINATION GLOVE, WITH PROTEIN CONTENT LABELING CLAIM, Substantially Equivalent on 2012-01-18. Applicant: Top Calibre Sdn Bhd. Device class: 1.
Clearance details
- Applicant
- Top Calibre 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
- Shah Alam, MY
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More clearances from Top Calibre Sdn Bhd
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