Powder Free Polychloroprene Examination Glove Blue, Powder Free Polychloroprene Examination Glove Pink— 510(k) K161932
Substantially EquivalentTerang Nusa Sdn Bhd
FDA 510(k) clearance K161932 for Powder Free Polychloroprene Examination Glove Blue, Powder Free Polychloroprene Examination Glove Pink, Substantially Equivalent on 2016-11-28. Applicant: Terang Nusa Sdn Bhd.
Clearance details
- Applicant
- Terang Nusa Sdn Bhd
- Product code
- Code LZA
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Kota Bharu, MY
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.