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The Surgical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. This 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, provided non-sterile.

Device Description

The Surgical Face Masks are blue color, single use, three-layer, flat-folded masks with nose piece and ear loops. The blue colorant is polypropylene (PP) master batch.

The Surgical Face Masks are manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter.

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 or fiberglass.

The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of Iron core coated with polypropylene resin.

The surgical face masks are sold non-sterile and are intended to be single use, disposable devices.

AI/ML Overview

This document describes the premarket notification (510(k)) for a Surgical Face Mask (K211897), comparing it to a predicate device (K182515). The acceptance criteria and the study proving the device meets them are detailed in the "Summary of Non-Clinical Test" section.

Here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance:

Test Method (Purpose)	Acceptance Criteria	Reported Device Performance	Result
Bacterial Filtration Efficiency (BFE) (%) (ASTM F2101-19)	≥98%	94/96 samples passed at ≥99%	Pass
Differential Pressure (mmH2O/cm²) (EN 14683: 2019, Annex C)	<6.0 mmH2O/cm²	92/96 samples passed at <4 mmH2O/cm²	Pass
Sub-micron Particulate Filtration Efficiency (PFE) at 0.1 micron (%) (ASTM F2299-03)	≥98%	96/96 samples passed at ≥99%	Pass
Resistance to Penetration by Synthetic Blood (mmHg) (ASTM F1862M-17)	Fluid resistant claimed at 160 mm Hg	95 of 96 test articles passed at 160mmHg	Pass
Flammability (ASTM F2100:2019, 16 CFR Part 1610) (Flame spread)	Class 1 (≥3 seconds burn Time)	96/96 samples passed at ≥3 seconds burn time - Class 1	Pass

Biocompatibility Testing (According to ISO 10993-1:2009 for surface device, skin contact, ≤24h duration):

Test Method (Purpose)	Acceptance Criteria	Reported Device Performance	Result
In vitro Cytotoxicity Test (ISO 10993-5:2009)	Device extract determined to be non-cytotoxic	Subject device extract was determined to be non-cytotoxic	Same (Pass)
Skin Sensitization Tests (ISO 10993-10:2010)	Device extract determined to be non-sensitizer	Subject device extract was determined to be non-sensitizer	Same (Pass)
Skin Irritation Tests (ISO 10993-10:2010)	Device extract determined to be non-irritant	Subject device extract was determined to be non-irritant	Same (Pass)

2. Sample size used for the test set and the data provenance:

Sample Size for performance tests (BFE, Delta-P, PFE, Synthetic Blood Penetration, Flammability): 3 lots were tested, with a total of 96 samples (e.g., "3 lots tested with total 96 samples"). This implies 32 samples per lot.
Sample Size for Biocompatibility tests: The document doesn't explicitly state the sample size for biocompatibility tests (e.g., number of test articles or subjects used in in vitro or in vivo studies for cytotoxicity, irritation, and sensitization). It only states that the tests "were conducted."
Data Provenance: Not explicitly stated regarding country of origin for the test data. The manufacturer is "ZHEJIANG HONGYU MEDICALI COMMODITY CO., LTD" from Yiwu City, Zhejiang Province, China, suggesting the testing likely occurred in China.
Retrospective or Prospective: The testing described is non-clinical performance testing, which is generally conducted prospectively for regulatory submission purposes.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. For this type of device (surgical face mask) and the non-clinical performance tests conducted, "ground truth" is established by direct measurement against established international standards (ASTM, EN, ISO). There is no "expert consensus" on image interpretation or diagnosis involved.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not Applicable. As mentioned above, this is non-clinical performance testing based on direct measurements and adherence to specified pass/fail criteria within the standards. There is no need for expert adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not Applicable. This submission is for a surgical face mask, not an AI-assisted diagnostic device. Therefore, no MRMC study or AI assistance evaluation was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not Applicable. This is a physical medical device, not a software algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Standardized Test Methods and Criteria: The "ground truth" for the device's performance is defined by the acceptance criteria specified in the relevant international standards (ASTM, EN, ISO, CFR). For example, the "truth" for bacterial filtration efficiency is a measured percentage, compared to a required percentage (e.g., ≥98%).

8. The sample size for the training set:

Not Applicable. This device is a physical product, not a machine learning model; therefore, there is no "training set" in the context of data used to train an algorithm.

9. How the ground truth for the training set was established:

Not Applicable. (As above, no training set for a physical product.)

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