510(k) clearance
Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and Black Color)
- 510(k) number
- K261793
- Applicant
- Maxter Healthcare, Inc.
- Decision date
- Sep 9, 2026
- Date received
- May 29, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- LZA
- Device type
- Polymer Patient Examination Glove
- Device class
- Class I
- Regulation
- 21 CFR 880.6250
- Advisory committee
- General Hospital
- Statement or summary
- Summary
- Third party
- N
- Location
- Rosharon, TX, US