FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NON-STERILE ISOLATION GOWN
K Number: K970814
·
Decision May 27, 1997
Classifications
1
FEI Numbers
58
Registration Numbers
58
Same Product Code
67
Applicant Total
6
Review Days
82
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Basic Information
- Device Name
- NON-STERILE ISOLATION GOWN
- K Number
- K970814
- 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
- American Seal Co.
- Date Received
- March 6, 1997
- Decision Date
- May 27, 1997
- Product Code
- FYC
- 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 |
|---|---|---|---|
| FYC | Gown, Isolation, Surgical | FDA class 2 | General, Plastic Surgery |
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Other Clearances by American Seal Co.
| K Number | Device Name | ||
|---|---|---|---|
| K972187 | BOUFFANT CAP | Sep 9, 1997 | Substantially Equivalent |
| K972227 | SHOE COVER | Sep 9, 1997 | Substantially Equivalent |
| K964358 | AMSEAL SURGICAL FACE MASK | Feb 14, 1997 | Substantially Equivalent |
| K892557 | MAYTEX NON-STERILE LATEX EXAM GLOVE | May 31, 1989 | Substantially Equivalent |
| K892553 | MAYTEX PATIENT EXAMINATION GLOVES | May 25, 1989 | Substantially Equivalent |