STERILE NITRILE SURGICAL GLOVES (POWDERED)— 510(k) K012479
Substantially EquivalentSmart Glove Corp. Sdn Bhd
FDA 510(k) clearance K012479 for STERILE NITRILE SURGICAL GLOVES (POWDERED), Substantially Equivalent on 2001-09-26. Applicant: Smart Glove Corp. Sdn Bhd. Device class: 1.
Clearance details
- Applicant
- Smart Glove Corp. Sdn Bhd
- Product code
- Code KGO
- Device class
- Class 1
- Regulation
- 21 CFR 878.4460
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Klang Selangor, MY
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More clearances from Smart Glove Corp. Sdn Bhd
view all- K091147 — POWDER FREE NITRILE EXAMINATION GLOVE (BLUE)
- K082370 — POWDER FREE NITRILE EXAMINATION GLOVE (BLUE)
- K081466 — STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
- K071170 — POWDER FREE NITRILE EXAMINATION GLOVES, MAGENTA AND WHITE COLOR COATED WITH ALLOGEL
- K063627 — POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE)
Data sourced from openFDA. This site is unofficial and independent of the FDA.