510(k) clearance
HALYARD* CHEMO360 Procedure Gown Tested for use with Chemotherapy Drugs (L, XXL); HALYARD* Procedure Gown Tested for use with Chemotherapy Drugs (L, XXL)
- 510(k) number
- K260310
- Applicant
- O&M Halyard, Inc.
- Decision date
- Oct 28, 2026
- Date received
- Jan 30, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- QSO
- Device type
- Medical Gowns With Chemotherapy Labeling Claims - Tested For Use With Chemotherapy Drugs
- Device class
- Class II
- Regulation
- 21 CFR 878.4040
- Advisory committee
- General, Plastic Surgery
- Statement or summary
- Summary
- Third party
- N
- Location
- Alpharetta, GA, US