Medical disposable face mask non sterile— 510(k) K202650
Substantially EquivalentGuangdong Zhong Ling Industrial Group Co., Ltd.
FDA 510(k) clearance K202650 for Medical disposable face mask non sterile, Substantially Equivalent on 2021-03-24. Applicant: Guangdong Zhong Ling Industrial Group Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Guangdong Zhong Ling Industrial Group 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
- Xinhe Wanjiang, Dongguan, 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
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.