K251319
- 510(k) number
- K251319
- Device name
- Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) Extended Cuff
- Applicant
- Hartalega NGC Sdn. Bhd. MY
- Product code
- LZA — Polymer Patient Examination Glove
- Decision date
- 2025-07-30
- Date received
- 2025-04-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K251319.pdf
Official FDA record: K251319
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.