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510(k) Data Aggregation
(99 days)
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. This is a single use, disposable device, provided sterile.
The proposed device Disposable Surgical Gown is model UM-148, its body, sleeve and belt are made of SMMS non-woven material, and cuff is made of polyester. The proposed device is available in sizes: S(120×135cm), M(125×140cm), L(130×145cm) and XL(135×150cm). 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 a blue color.
The provided text describes a 510(k) premarket notification for a medical device, specifically a "Disposable Surgical Gown (UM-148)". This type of submission aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. Therefore, the "acceptance criteria" and "study" described are about showing that the new surgical gown performs comparably to established standards and a predicate device, rather than proving a new clinical claim.
Here's an analysis of the provided information, formatted as requested:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria / Standard (Ref.) | Reported Device Performance |
|---|---|
| AAMI/ANSI PB70:2012, Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended For Use In Health Care Facilities. Level 3: When tested for water resistance in accordance with AATCC 42 (impact penetration) and AATCC 127 (hydrostatic pressure) and all critical zone components shall have a blotter weight gain of no more than 1.0 g and a hydrostatic pressure of >50 cm. | Level 3 (The device meets Level 3 requirements for Liquid Barrier Performance and Classification) |
| ASTM D5587-15, Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure: ≥10 N | PASS |
| MD: 45.5N | |
| CD: 28.2N (Average result from 10 samples) | |
| ASTM D5034-09 (2017) Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test): ≥30N | PASS |
| MD: 145.4N | |
| CD: 91.4N (Average result from 10 samples) | |
| ASTM D1683M-17 Standard Test Method for Failure in Sewn Seams of Woven Fabrics: ≥30N | PASS |
| 52.6N (Average result from 10 samples) | |
| AATCC 42-2013, Water Penetration Resistance: Impact Penetration Test: ≤1.0 g | PASS |
| 0 g (Average result from 3 nonconsecutive batches) | |
| Evaporative Resistance ASTM F1868-17: 50 cm | PASS |
| 65~72 cm (Average result from 3 nonconsecutive batches) | |
| CPSC 16 CFR Part 1610-2008, Standard for the Flammability of clothing textiles: Meets Class I requirements | PASS |
| Class I (Average result from 5 samples) | |
| **ISO 9073- 10:2003(E) Lint and Other Particles Generation: Log10(particle count) |
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(60 days)
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. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This a single use, disposable device(s), provided non-sterile.
Surgical Face Mask is composed of Nylon and Spandex ear loops, Iron-plastic nose clip, Inner layer Spunbond polypropylene, Middle Melt-blown polypropylene and outer Spun-bond polypropylene. The meltblown polypropylene material acts as the filter that stops microbes from entering or exiting the mask. Surgical Face Masks feature pleats or folds. Three pleats are used to allow the user to expand the mask such that it covers the area from the nose to the chin. The type is ear-loop, where a string-like material is attached to the mask and placed behind the ears. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
The provided document describes the non-clinical testing performed for a Surgical Face Mask (Model: 17.5X9.5CM EAR-LOOP) to demonstrate its substantial equivalence to a legally marketed predicate device. This is not an AI/ML medical device, and therefore, the requested information regarding AI/ML-specific study aspects (like expert ground truth establishment, MRMC studies, training/test set details, etc.) is not applicable to this document.
The document focuses on the physical performance and biocompatibility of the surgical face mask, comparing it to established industry standards for surgical apparel.
Here's the relevant information extracted and presented based on the document:
Device: Surgical Face Mask, Model: 17.5X9.5CM EAR-LOOP
Regulatory Class: Class II
Product Code: FXX
Regulation Number: 21 CFR 878.4040 (Surgical Apparel)
Predicate Device: K203426, Surgical Face Mask (non-sterile)
Study Type: Non-clinical (performance and biocompatibility)
Clinical Test Conclusion: No clinical study was included in this submission.
1. Table of Acceptance Criteria and Reported Device Performance
The device is evaluated against ASTM F2100-19 Level 2 performance standards and ISO 10993 for biocompatibility.
| Item | Purpose | Acceptance Criteria (ASTM F2100-19 Level 2) | Reported Device Performance (Result; average performance if provided) |
|---|---|---|---|
| Fluid Resistance (ASTM F1862) | Assess the performance of a mask to resistance to a synthetic blood preparation targeted toward the mask at a set pressure | 29 out of 32 pass at 120 mmHg | PASS (Results for individual lots not detailed beyond "PASS" matching the criteria) |
| Particulate Filtration Efficiency (ASTM F2299) | Assess the performance of a mask to penetration by sub-micron polystyrene latex particles of 0.1 micron | ≥ 98% | PASS (Lot1: 99.17%, Lot2: 99.49%, Lot3: 98.90%) |
| Bacterial Filtration Efficiency (ASTM F2101) | Assess the performance of a mask to penetration by a prepared solution with known concentration of an indicator bacterial organism | ≥ 98% | PASS (Lot1: 99.87%, Lot2: 99.9%, Lot3: 99.84%) |
| Differential Pressure (Delta P) (EN 14683 Annex C) | Assess the performance of a mask for resistance to air movement through the materials of the face of the mask |
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