K241528
- 510(k) number
- K241528
- Device name
- Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential
- Applicant
- Comfort Rubber Gloves Industries Sdn. Bhd. MY
- Product code
- LZA — Polymer Patient Examination Glove
- Decision date
- 2024-08-06
- Date received
- 2024-05-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K241528.pdf
Official FDA record: K241528
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.