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510(k) Data Aggregation
(428 days)
Lyncmed Medical Technology (Beijing) Co., Ltd.
The disposable surgical face mask is intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials.
The proposed device, Disposable Surgical Face Mask is a three-layer, flat-folded mask. The mask body is made of 25g/m2 polypropylene (PP) non-woven cloth. The mask contains tie strings or ear loop to secure the mask over the users' mouth and face and includes a nosepiece to provide a firm fit over the nose. Ear loops are made of Polyurethane and spandex, and tie strings are made of polypropylene nonwoven cloth. The nose clip which is made of Iron-Zinc strip covered by polyethylene terephthalate (PET) covering. The disposable surgical face mask is available in two different specifications: 17.5×9.5cm and 16.5×8.5cm. The device is single use and provided sterile.
The document describes the testing and acceptance criteria for a "Disposable Surgical Face Mask" (K212649). This is a medical device, not an AI/ML device, therefore, many of the requested categories such as "Number of experts used to establish the ground truth," "Adjudication method," "MRMC comparative effectiveness study," and "sample size for the training set" are not applicable.
Here's the information extracted and organized as requested, with "N/A" for sections not relevant to a non-AI medical device submission:
1. Table of Acceptance Criteria and Reported Device Performance
| No | Item | Test Method/Standard | Type | Acceptance Criteria | Reported Performance for Ear Loop Type | Reported Performance for Tie-on Type |
|---|---|---|---|---|---|---|
| 1 | Particulates Filtration Efficiency | ASTM F2299/F2299M-03(2017) | Ear loop | ≥98% | Lot 1: 98.81% | |
| Lot 2: 98.78% | ||||||
| Lot 3: 98.8% | N/A (listed separately below) | |||||
| Tie-on | ≥98% | N/A (listed above) | Lot 1: 98.82% | |||
| Lot 2: 98.78% | ||||||
| Lot 3: 98.79% | ||||||
| 2 | Bacterial Filtration Efficiency | ASTM F2101-19 | Ear loop | ≥98% | Lot 1: 99.9% | |
| Lot 2: 99.91% | ||||||
| Lot 3: 99.91% | N/A (listed separately below) | |||||
| Tie-on | ≥98% | N/A (listed above) | Lot 1: 99.91% | |||
| Lot 2: 99.9% | ||||||
| Lot 3: 99.91% | ||||||
| 3 | Fluid Resistance | ASTM F1862/F1826M-17 | Ear loop | 120 mmHg | Lot 1: No penetration at 120 mmHg | |
| Lot 2: No penetration at 120 mmHg | ||||||
| Lot 3: No penetration at 120 mmHg | N/A (listed separately below) | |||||
| Tie-on | 120 mmHg | N/A (listed above) | Lot 1: No penetration at 120 mmHg | |||
| Lot 2: No penetration at 120 mmHg | ||||||
| Lot 3: No penetration at 120 mmHg | ||||||
| 4 | Differential Pressure | EN 14683:2019 | Ear loop | △P |
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(161 days)
Lyncmed Medical Technology (Beijing) Co., Ltd.
The Nitrile Examination Gloves is a non-sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
The proposed device, Nitrile Examination Gloves (Blue, Violet) are disposable devices intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. The proposed devices are Powder Free Nitrile Examination Gloves and includes variations of different size and color. The color of the proposed device is Blue and Violet. The proposed device is not provided as sterilized. The proposed device is made of Nitrile.
This document describes the performance testing for Nitrile Examination Gloves (Blue, Violet). Here's a breakdown of the acceptance criteria and study details:
Acceptance Criteria and Reported Device Performance
Device: Nitrile Examination Gloves (Blue, Violet)
Purpose: Non-sterile disposable device worn to prevent contamination between patient and examiner.
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D5151 | Testing for Freedom from Holes | Freedom from holes AQL 2.5 | Blue Color: No water leakage inspected from 200 samples |
| Violet Color: No water leakage inspected from 200 samples | |||
| ASTM D6124 | Determine the powder residue for powder free gloves |
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