STERILE LATEX EXAMINATION GLOVES (POWDERED) WITH PROTEIN CLAIM LESS THAN 100UG/G— 510(k) K012856
Substantially EquivalentSmart Glove Corp. Sdn Bhd
FDA 510(k) clearance K012856 for STERILE LATEX EXAMINATION GLOVES (POWDERED) WITH PROTEIN CLAIM LESS THAN 100UG/G, Substantially Equivalent on 2001-11-16. Applicant: Smart Glove Corp. Sdn Bhd. Device class: 1.
Clearance details
- Applicant
- Smart Glove Corp. 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
- Klang Selangor, MY
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- K071170 — POWDER FREE NITRILE EXAMINATION GLOVES, MAGENTA AND WHITE COLOR COATED WITH ALLOGEL
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Data sourced from openFDA. This site is unofficial and independent of the FDA.