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510(k) Data Aggregation
(107 days)
Xiantao Topmed Nonwoven Protective Products Co., Ltd.
The Disposable Surgical Gowns are intended to be worn by operating room personnel during surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate matter.
In addition, this surgical gown meets the requirements of AAMI Level 3 barrier protection for a surgical gown per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70). This is a single use, disposable device, provided sterile. The surgical gown has six sizes - S, M, L, XL, XXL and XXXL.
The Disposable surgical gown is composed of collar, body, sleeve and tie. The back is full opening, the neck and waist are laced, the sleeve are made of cotton closure by sewing, and the rest are made of heat sealing. It has been tested according to AAMI PB70:2012 and meet AAMI Level 3 barrier level protection for a surgical gown.
The document details the non-clinical testing performed for the Disposable Surgical Gown (G4003) to support its substantial equivalence claim.
1. Table of acceptance criteria and the reported device performance
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Tearing Strength | Evaluate the tearing strength of the test sample. | ≥ 10N | Pass: MD: average 52.03N, CD: average 29.15N |
| Tensile Strength | Evaluate the breaking strength of the test sample. | ≥ 30N | Pass: MD: average 135.83N, CD: average 98.25N |
| Seam Strength | Evaluate the seam strength of the test sample. | ≥ 30N | Pass: Average 45.18N |
| Impact Penetration | Evaluate the water impact of the test sample. | ≤1.0 g | Pass: 0.16g max |
| Hydrostatic Pressure | Determine the hydrostatic pressure of the test sample. | >50 cm | Pass: 52~98cm |
| Thermal and Evaporative Resistance | Evaluate the evaporative resistance of the test sample. |
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(88 days)
Xiantao Topmed Nonwoven Protective Products Co., Ltd.
The Disposable Medical Face Masks are 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(s), provided non-sterile.
The Disposable Medical Face Mask is blue color, single use, flat-folded masks with nose piece and ear loops. The blue colorant is polypropylene (PP) master batch.
The body of the mask is composed of three layers: the inner and outer layers are made of polypropylene spun-bond nonwoven fabric, and the middle layer is made of polypropylene melt blown non-woven fabric. The nose clip is made of Galvanized iron wire coated by PE, and the ear loop is made of polyester and spandex.
The disposable medical face masks are sold non-sterile and are intended to be single use, disposable devices.
This document is a 510(k) Premarket Notification for a Disposable Medical Face Mask. It focuses on demonstrating that the proposed device is substantially equivalent to a legally marketed predicate device (K210433) by providing non-clinical test data.
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (ASTM F2100 Level 3) | Reported Device Performance |
|---|---|
| Fluid Resistance: 29 out of 32 pass at 160 mmHg | Pass: 32 out of 32 pass at 160 mmHg, 3 lots |
| Particulate Filtration Efficiency: $\ge$ 98% | Pass: Average 99.36% |
| Bacterial Filtration Efficiency: $\ge$ 98% | Pass: Average 99.40% |
| Differential Pressure (Delta P): |
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