K251141
- 510(k) number
- K251141
- Device name
- Powder Free Nitrile Patient Examination Glove, Blue colored, Non-sterile Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Patient Examination Glove, Black colored, Non-sterile Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
- Applicant
- Mercator Medical (Thailand), Ltd. TH
- Product code
- LZA — Polymer Patient Examination Glove
- Decision date
- 2025-11-17
- Date received
- 2025-04-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K251141
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.