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510(k) Data Aggregation
(56 days)
Jiangsu Medplus Non-woven Manufacturer Co., Ltd.
Surgical gown is intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.
Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the Level 2 standard surgical gowns met the requirements for Level 2 classification, the Level 3 standard surgical gowns and Level 3 reinforced surgical gowns met the requirements for Level 3 classification.
The proposed devices are intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. The proposed devices are single use, disposable medical devices and are provided in sterile.
There are three types of surgical gown: Level 2 standard surgical gown, Level 3 standard surgical gown and Level 3 reinforced surgical gown. And each type of surgical gown is available in seven product sizes, including XS, S, M, L, XL, XXL and XXXL. The barrier protection level for Level 2 standard surgical gown meets AAMI Level 2, while the barrier protection level for Level 3 standard surgical gown and Level 3 reinforced surgical gown meet AAMI Level 3.
Acceptance Criteria and Device Performance Study for Surgical Gowns (K211422)
This document describes the acceptance criteria and the studies performed to demonstrate that the Jiangsu Medplus Non-woven Manufacturer Co., Ltd. Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, and Level 3 Reinforced Surgical Gown meet these criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Name of Testing Methodology | Acceptance Criteria (Proposed Device) | Reported Device Performance |
|---|---|---|
| Flammability (16 CFR Part 1610) | Meets Class 1 requirements | Pass |
| Hydrostatic pressure (AATCC 127: 2017) | Level 2 Standard Surgical Gown: >20 cm | |
| Level 3 Standard Surgical Gown: >50 cm | ||
| Level 3 Reinforced Surgical Gown: >50 cm | Level 2 Standard Surgical Gown: 37.6 cm | |
| Level 3 Standard Surgical Gown: 52.6 cm | ||
| Level 3 Reinforced Surgical Gown: 83.1 cm | ||
| Water impact (AATCC 42: 2017) | ≤1.0 g | Level 2 Standard Surgical Gown: 0.4 g |
| Level 3 Standard Surgical Gown: 0.5 g | ||
| Level 3 Reinforced Surgical Gown: 0.2 g | ||
| Breaking strength (ASTM D5034: 2009(2017)) | >20N | Level 2 Standard Surgical Gown: 73N |
| Level 3 Standard Surgical Gown: 70.3N | ||
| Level 3 Reinforced Surgical Gown: 45.6N | ||
| Tearing strength (ASTM D5587: 2015(2019)) | >20N | Level 2 Standard Surgical Gown: 24.1N |
| Level 3 Standard Surgical Gown: 48.4N | ||
| Level 3 Reinforced Surgical Gown: 24.6N | ||
| Linting (ISO 9073-10: 2003) | Log10 (particle count) 30 ft³/min/ft² | Level 2 Standard Surgical Gown: 32.9 ft³/min/ft² |
| Level 3 Standard Surgical Gown: 33.8 ft³/min/ft² | ||
| Level 3 Reinforced Surgical Gown: 31.7 ft³/min/ft² | ||
| EO/ECH Residue (ISO 11135:2014 Annex B) | EO: |
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(155 days)
Jiangsu Medplus Non-woven Manufacturer Co., Ltd.
The device is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are 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.
The proposed devices, Standard Procedure Mask and Standard Surgical Mask, are a three-layer, singleuse, flat-pleated mask. Both the two masks have the same indications for use. The Standard Procedure Mask is an ear-loop surgical mask, and the Standard Surgical Mask is a tie-on surgical mask. The color of the proposed devices is blue. They are provided in non-sterile.
This document describes the performance testing of a medical device, specifically a Standard Procedure Mask and a Standard Surgical Mask, to demonstrate substantial equivalence to a predicate device (K153496) for FDA 510(k) clearance.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Name of the Test Methodology / Standard | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Resistance to Penetration by Synthetic Blood | To evaluate the effectiveness of the test sample from possible exposure to blood and other body fluids. | No penetration at 120 mmHg | Pass at 120mmHg |
| Bacterial Filtration Efficiency (BFE) | To determine the bacterial filtration efficiency (BFE) of the test article. | $\ge 98%$ | Average 98.61% |
| Particulate Filtration Efficiency (PFE) | To determine the Particle Filtration Efficiency. | $\ge 98%$ | Average 98.58% |
| Differential Pressure (Breathability) | To determine the differential pressure, indicating how easily one can breathe through the mask. | $ |
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