Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims.— 510(k) K211022
Substantially EquivalentCentral Medicare Sdn Bhd
FDA 510(k) clearance K211022 for Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims., Substantially Equivalent on 2021-12-22. Applicant: Central Medicare Sdn Bhd.
Clearance details
- Applicant
- Central Medicare Sdn Bhd
- Product code
- Code LZA
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Teluk Intan, 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.