POWDER FREE NITRILE EXAMINATION GLOVE, GRAPE SCENTED (BLUE AND WHITE)— 510(k) K061724
Substantially EquivalentSmart Glove Corp. Sdn Bhd
FDA 510(k) clearance K061724 for POWDER FREE NITRILE EXAMINATION GLOVE, GRAPE SCENTED (BLUE AND WHITE), Substantially Equivalent on 2006-07-25. Applicant: Smart Glove Corp. Sdn Bhd. Device class: 1.
Clearance details
- Applicant
- Smart Glove Corp. Sdn Bhd
- Product code
- Product code LZA
- Device class
- Class 1
- Regulation
- 21 CFR 880.6250
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Selangor Darul Eshan, 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)
Adverse events under product code LZA
product code LZA- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.