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510(k) Data Aggregation
(126 days)
Ammex-Weida (Hubei) Health and Safety Products Co., Ltd
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 material. This surgical gown meets the requrements of AAMI Level 3 barrier protection for a surgical gown per ANSI/A AMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70). The Surgical Gowns are single use, disposable medical devices, provided sterile.
The proposed device Surgical Gown is model 40083, its body, sleeve and belt are made of SSMMS non-woven material, and cuff is made of cotton. The proposed device is available in XS, S, M, L, XL, 2XL, 3XL sizes. This proposed device can meet the requirements for Level 3 per ANSI/AAMI PB70:2012. The proposed devices are disposable medical devices and provided in sterile and blue color.
This document is a 510(k) Premarket Notification from the FDA regarding a Surgical Gown. It evaluates the device's substantial equivalence to a legally marketed predicate device. The information provided is primarily focused on the physical and barrier performance characteristics of the surgical gown, not an AI/Software as a Medical Device (SaMD) product.
Therefore, most of the requested information regarding AI/SaMD performance criteria, such as "number of experts used to establish ground truth," "adjudication method," "MRMC study," "standalone algorithm performance," and "training set details," is not applicable to this submission.
However, I can extract the relevant information regarding the surgical gown's acceptance criteria and the studies proving it meets those criteria:
Device: Surgical Gown (Model 40083)
Intended Use: To be worn by operating room personnel during surgical procedures to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. It meets AAMI Level 3 barrier protection.
Acceptance Criteria and Reported Device Performance:
| Test Item | Test Standard | Acceptance Criteria | Reported Device Performance (Result) |
|---|---|---|---|
| Seam Strength | ASTM D1683M-17 | ≥30N (7lbf) per standard F2407-20 for Level 3 | PASS: 68.46 N (Average result from 30 samples) |
| Breaking Strength | ASTM D5034-09 (2017) | ≥30N (7lbf) per standard F2407-20 for Level 3 | PASS: MD: 120.61N, CD: 88.19N (Average result from 30 samples) |
| Tear Strength (N) | ASTM D5587-15 | ≥20N | PASS: MD: 60.03N, CD: 39.78N (Average result from 30 samples) |
| Lint and other generation in the dry state | ISO 9073-10:2003(E) | Log10(particle count) |
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(60 days)
Ammex-Weida (Hubei) Health and Safety Products Co., Ltd
The 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. They are in infection control practices to reduce the potential exposure to blood and body fluids. This a single use, disposable device(s), provided non-sterile.
The proposed device(s) are blue color, and flat pleated type mask, utilizing ear loops way for wearing, and they all has nose clips design for fitting the face mask around the nose. The proposed device(s) 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 model of proposed device, ear loops, is held in place over the users' mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are made of Nylon and polyester. The nose piece contained in the proposed device(s) is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of polyethylene coated galvanized wire. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
This document pertains to the 510(k) premarket notification for a Medical Face Mask, and as such, it describes performance testing for a physical medical device, not software or an AI-powered diagnostic tool. Therefore, many of the requested criteria related to AI/algorithm performance, ground truth establishment, expert adjudication, and MRMC studies are not applicable.
However, I can extract the relevant information regarding the device's acceptance criteria and the studies performed to demonstrate it meets those criteria.
Acceptance Criteria and Device Performance for Ammex-Weida (Hubei) Health and Safety Products Co., Ltd's Medical Face Mask
The device under review is a Medical Face Mask, a physical device, not an AI/algorithm-based one. The acceptance criteria are based on established performance standards for medical face masks.
1. Table of Acceptance Criteria and Reported Device Performance
Device: Medical Face Mask (Proposed Device, K211062)
Classification: Class II, ASTM F2100 Level 3 (meets Level 3 requirements)
| Performance Characteristic | Acceptance Criteria (ASTM F2100 Level 3) | Reported Device Performance (Proposed Device) | Result |
|---|---|---|---|
| Fluid Resistance (ASTM F1862) | 29 out of 32 Pass at 160 mmHg | 32 out of 32 Pass at 160 mmHg | PASS |
| Particulate Filtration Efficiency (ASTM F2299) | ≥ 98% | 98.98% | PASS |
| Bacterial Filtration Efficiency (ASTM F2101) | ≥ 98% | 99.9% | PASS |
| Differential Pressure (Delta P) (EN 14683 Annex C) |
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