FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Medical surgical mask (Black mask, Level 1 and Level 3)
K Number: K213450
·
Decision Apr 5, 2022
Classifications
1
FEI Numbers
315
Registration Numbers
315
Same Product Code
606
Applicant Total
14
Review Days
161
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Basic Information
- Device Name
- Medical surgical mask (Black mask, Level 1 and Level 3)
- K Number
- K213450
- 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
- Guangdong Kingfa Sci. & Tech.Co., Ltd.
- Date Received
- October 26, 2021
- Decision Date
- April 5, 2022
- Product Code
- FXX
- 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 |
|---|---|---|---|
| FXX | Mask, Surgical | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Guangdong Kingfa Sci. & Tech.Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K233723 | Medical surgical mask | Jul 29, 2024 | Substantially Equivalent |
| K231155 | Biodegradable Medical surgical mask | Nov 7, 2023 | Substantially Equivalent |
| K221983 | Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Biodegradable Powder Free Nitrile Examination Glove, Blue Violet Color, Biodegradable Powder Free Nitrile Examination Glove, Green Color | Apr 27, 2023 | Substantially Equivalent |
| K230046 | Vinyl examination gloves | Mar 25, 2023 | Substantially Equivalent |
| K222612 | Powder-Free Latex examination gloves | Nov 25, 2022 | Substantially Equivalent |
| K222714 | Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Black Tested For Use With Chemotherapy Drugs | Oct 7, 2022 | Substantially Equivalent |
| K221887 | Nitrile Examination Glove, Pink Color; Nitrile Examination Glove, Black Color, Nitrile Examination Glove, White Color | Sep 24, 2022 | Substantially Equivalent |
| K213040 | Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs,Nitrile Patient Examination Gloves Black Tested For Use With Chemotherapy Drugs | Apr 27, 2022 | Substantially Equivalent |
| K211220 | Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs | Jul 22, 2021 | Substantially Equivalent |
| K203593 | Patient Examination Gloves | Mar 19, 2021 | Substantially Equivalent |