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. · General, Plastic Surgery
Open FDA's page for this record- Third party flag
- N
- City
- Edmonton
- Advisory committee description
- General, Plastic Surgery
- Address 1
- 200, 2003-91 St. SW
- Statement or summary
- Summary
- Product code
- QSO
- Zip code
- T6X 0W8
- Applicant
- PRIMED Medical Products, Inc.
- Decision date
- 2026-09-01
- Decision code
- SESE
- Country code
- CA
- Advisory committee
- SU
- Contact
- Mitra Fard
- K number
- K261811
- Date received
- 2026-06-01
- Review advisory committee
- HO
- Postal code
- T6X 0W8
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Device name
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)
- Harmonized identifiers (openFDA)
- Device name
- Medical Gowns With Chemotherapy Labeling Claims - Tested For Use With Chemotherapy Drugs
- Medical specialty description
- General, Plastic Surgery
- Regulation number
- 878.4040
- Device class
- 2
- Registration number
- 3017171460, 1417592, 3003561450, 9681151, 3012344767, 3011545608
- FEI number
- 3017171460, 1417592, 3003792528, 3003561450, 3012344767, 3011545608