FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Disposable Surgical Gown
K Number: K210510
·
Decision Aug 12, 2021
Classifications
1
FEI Numbers
222
Registration Numbers
222
Same Product Code
294
Applicant Total
8
Review Days
171
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Basic Information
- Device Name
- Disposable Surgical Gown
- K Number
- K210510
- 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
- Shandong Zhushi Pharmaceutical Group Co., Ltd.
- Date Received
- February 22, 2021
- Decision Date
- August 12, 2021
- 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 Shandong Zhushi Pharmaceutical Group Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K232475 | Disposable infusion set with needle | May 10, 2024 | Substantially Equivalent |
| K212033 | Disposable Sterile Syringe, with/without needle;luer/luer-lock, Disposable insulin syringe, Disposable Hypodermic needle | Aug 17, 2022 | Substantially Equivalent |
| K210643 | Disposable Surgical Face Mask | Aug 4, 2021 | Substantially Equivalent |
| K210409 | Disposable Surgical Face Mask | Jul 28, 2021 | Substantially Equivalent |
| K203454 | Infrared Thermometer | Apr 29, 2021 | Substantially Equivalent |
| K203436 | Disposable Nitrile Examination Gloves | Apr 28, 2021 | Substantially Equivalent |
| K203439 | Disposable Vinyl Examination Gloves | Feb 26, 2021 | Substantially Equivalent |