EMG Blue Nitrile Examination Gloves Powder Free with Tested for use with Chemotherapy Drugs— 510(k) K161187
Substantially EquivalentEco Medi Glove Sdn. Bhd.
FDA 510(k) clearance K161187 for EMG Blue Nitrile Examination Gloves Powder Free with Tested for use with Chemotherapy Drugs, Substantially Equivalent on 2016-09-09. Applicant: Eco Medi Glove Sdn. Bhd..
Clearance details
- Applicant
- Eco Medi Glove Sdn. Bhd.
- Product code
- Code LZA
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Taiping, 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.