510(k) K260310
- Device
- HALYARD* CHEMO360 Procedure Gown Tested for use with Chemotherapy Drugs (L, XXL); HALYARD* Procedure Gown Tested for use with Chemotherapy Drugs (L, XXL)
- Applicant
- O&M Halyard, Inc.
- 510(k) number
- K260310
- Product code
- QSO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-10-28
- Date received
- 2026-01-30
- Regulation
- 878.4040
- Classification name
- Medical Gowns With Chemotherapy Labeling Claims - Tested For Use With Chemotherapy Drugs
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Natrisya Nur Abdul Rahman
- Address
- 1220 Old Alpharetta Rd. Suite 320 Alpharetta GA US 30005 30005
FDA Registration Numbers#
- 9681151
- 1417592
- 9615270
- 3011545608
- 3020755815
- 3017171460
- 3009540572
- 3012344767
- 3003561450
- 3005599545
Source Documents#
Other 510(k) Records For Product Code QSO#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261811 | PRIMED Chemotherapy Drug Tested Gowns (PM4-99450: PRIMED Chemotherapy Drug Tested Isolation Gown, Purple, AAMI Level 2; PM4-99460: PRIMED Chemotherapy Drug Tested Isolation Gown, Blue, AAMI Level 3) | PRIMED Medical Products, Inc. | 2026-09-01 |