Shamrock Powder Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl)— 510(k) K211810
Substantially EquivalentPt. Shamrock Manufacturing Corpora
FDA 510(k) clearance K211810 for Shamrock Powder Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl), Substantially Equivalent on 2022-05-23. Applicant: Pt. Shamrock Manufacturing Corpora.
Clearance details
- Applicant
- Pt. Shamrock Manufacturing Corpora
- Product code
- Code LZA
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Kab. Deli Serdang, ID
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.