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510(k) Data Aggregation
(343 days)
Ningbo Jingeao Electronics Inc.
The surgical mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. It is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non sterile.
The surgical mask is single use, three-layer, flat-pleated style with ear loops and nose piece. The mask is manufactured with three layers, the inner and outer layers are made of nonwoven fabrics, and the middle layer is made of melt blown fabrics. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of galvanized iron wire. The disposable medical face mask will be provided in blue. The masks are sold non-sterile and are intended to be single use, disposable devices.
The provided text describes the acceptance criteria and the results of non-clinical tests for a surgical mask (K202746). It explicitly states that no clinical study was implemented.
Here's a breakdown of the requested information based on the provided document:
1. A table of acceptance criteria and the reported device performance
| Items | Acceptance Criteria (Level 2, ASTM F2100-19) | Reported Device Performance (Result) |
|---|---|---|
| Bacterial filtration efficiency (BFE) (%) | ≥98 | 99.8~99.9% |
| Differential pressure (mmH2O/cm²) |
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(339 days)
Ningbo Jingeao Electronics Inc.
The Disposable medical face mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The face mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non sterile.
The disposable medical face mask is single use, three-layer, flat-pleated style with ear loops and nose piece. The mask is manufactured with three layers, the inner and outer layers are made of nonwoven fabrics, and the middle layer is made of melt blown fabrics. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of galvanized iron wire. The disposable medical face mask will be provided in blue. The masks are sold non-sterile and are intended to be single use, disposable devices.
The provided document describes the acceptance criteria and the study conducted for a Disposable Medical Face Mask (K202745), not an AI-powered medical device. Therefore, many of the requested fields related to AI/MRMC studies, number of experts, and ground truth establishment are not applicable.
However, I can extract the information relevant to the performance testing of the medical face mask as described in the document.
Here's a breakdown of the acceptance criteria and study results for the Disposable Medical Face Mask:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Item | Purpose | Acceptance Criteria (Level 2, ASTM F2100-19) | Reported Device Performance |
|---|---|---|---|
| Bacterial filtration efficiency (BFE) (%) | To evaluate Bacterial filtration efficiency (BFE) (%) | ≥98 | Pass |
| Differential pressure (mmH2O/cm²) | To evaluate Differential pressure (mmH2O/cm²) |
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