Biodegradable Medical surgical mask— 510(k) K231155
Substantially EquivalentGuangdong Kingfa Sci. & Tech.Co., Ltd.
FDA 510(k) clearance K231155 for Biodegradable Medical surgical mask, Substantially Equivalent on 2023-11-07. Applicant: Guangdong Kingfa Sci. & Tech.Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Guangdong Kingfa Sci. & Tech.Co., Ltd.
- Product code
- Code FXX
- Device class
- Class 2
- Regulation
- 21 CFR 878.4040
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Qingyuan, CN
Recent devices under product code FXX
view all- K251967 — HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops +1 more
- K252534 — Surgical Face Mask (Ear mount)
- K253398 — Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)
- K252830 — Disposable Surgical Face Mask (3P00B, C2900)
- K252650 — Disposable Medical Face Mask
More clearances from Guangdong Kingfa Sci. & Tech.Co., Ltd.
view all- K233723 — Medical surgical mask
- 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
- K230046 — Vinyl examination gloves
- K222612 — Powder-Free Latex examination gloves
- 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
Adverse events under product code FXX
product code FXX- Injury
- 137
- Total
- 137
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.