ELEGANT BLUE, WHITE, PINK POWDER FREE, NITRILE EXAMINATION GLOVES— 510(k) K101760
Substantially EquivalentProfit Point Manufacturing Sdn Bhd
FDA 510(k) clearance K101760 for ELEGANT BLUE, WHITE, PINK POWDER FREE, NITRILE EXAMINATION GLOVES, Substantially Equivalent on 2010-10-06. Applicant: Profit Point Manufacturing Sdn Bhd. Device class: 1.
Clearance details
- Applicant
- Profit Point Manufacturing 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
- Kluang, Johor, MY
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More clearances from Profit Point Manufacturing Sdn Bhd
view allAdverse 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.