FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Safecare Open Back Protective Gowns and ValueCare Open Back Protective Gowns
K Number: K160337
·
Decision Jul 7, 2017
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
8
Applicant Total
1
Review Days
515
Basic Information
- Device Name
- Safecare Open Back Protective Gowns and ValueCare Open Back Protective Gowns
- K Number
- K160337
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4040
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- BAM CORPORATION LIMITED
- Date Received
- February 8, 2016
- Decision Date
- July 7, 2017
- Product Code
- QPC
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QPC | Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (QPC), ordered by most recent decision date.
AAMI Level 4 Protective; Gown
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Medline Open-back Level 3 Protective Gown
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PolyWear® Personal Protective Level 3 Gown
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Protective Gown AAMI Level 4
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Dukal Corporation AAMI Level 4 Open-Back Protective Gown
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Donagamex Blue Performance Protective Gown
FDA 510(k)
FDA Class 2
·General, Plastic Surgery