FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇲 Comoros
DISPOSABLE SURGICAL GOWNS
K Number: K120192
·
Decision Oct 16, 2012
Classifications
1
FEI Numbers
222
Registration Numbers
222
Same Product Code
294
Applicant Total
6
Review Days
267
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Basic Information
- Device Name
- DISPOSABLE SURGICAL GOWNS
- K Number
- K120192
- 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
- Weihai Hongyu Nonwoven Fabric Products Co., Ltd.
- Date Received
- January 23, 2012
- Decision Date
- October 16, 2012
- Product Code
- FYA
- 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 |
|---|---|---|---|
| FYA | Gown, Surgical | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Weihai Hongyu Nonwoven Fabric Products Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K214088 | Disposable Surgical Gown | Apr 12, 2022 | Substantially Equivalent |
| K220133 | Sterilization Wraps | Mar 10, 2022 | Substantially Equivalent |
| K213029 | Nitrile Examination Gloves (Powder free, Blue) | Dec 14, 2021 | Substantially Equivalent |
| K212807 | Surgical Masks | Dec 3, 2021 | Substantially Equivalent |
| K141324 | HONGYU DISPOSABLE SURGICAL DRAPES | Apr 14, 2015 | Substantially Equivalent |