FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DISPOSABLE ISOLATION GOWN
K Number: K911921
·
Decision May 13, 1991
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
5
Applicant Total
6
Review Days
13
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Basic Information
- Device Name
- DISPOSABLE ISOLATION GOWN
- K Number
- K911921
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4040
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Liaoning-Usa Corp.
- Date Received
- April 30, 1991
- Decision Date
- May 13, 1991
- Product Code
- FYB
- 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 |
|---|---|---|---|
| FYB | Gown, Patient | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FYB), ordered by most recent decision date.
DISPOSABLE MEDICAL GOWNS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DENTAL BIB
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PROCEDURE & RECOVERY PATIENT SUIT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SHIELD DISP. PATIENTS PONCHO GOWNS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PEDIATRICS GOWN
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by Liaoning-Usa Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K905487 | VARIOUS TYPES OF STETHOSCOPES | Apr 9, 1991 | Substantially Equivalent |
| K910623 | GAUZE SPONGES ABSORBENT GAUZE ROLLS | Apr 1, 1991 | Substantially Equivalent |
| K902625 | CLINICAL THERMOMETER; RECTAL/ORAL, INNER ARMPIT | Oct 26, 1990 | Substantially Equivalent |
| K892781 | ANTELOPE BRAND PATIENT EXAMINATION GLOVES | Sep 21, 1989 | Substantially Equivalent |
| K892774 | PATIENT EXAMINATION GLOVES | Sep 13, 1989 | Substantially Equivalent |