Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs)— 510(k) K223235
Substantially EquivalentPt. Sintong Unigolden Glove
FDA 510(k) clearance K223235 for Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs), Substantially Equivalent on 2022-10-26. Applicant: Pt. Sintong Unigolden Glove.
Clearance details
- Applicant
- Pt. Sintong Unigolden Glove
- Product code
- Code LZA
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Kota Kisaran, 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.