Search Results
Found 19 results
510(k) Data Aggregation
(185 days)
Disposable Surgical Gown
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 material. This surgical gown meets the requirements of AAMI Level 3/Level 4 barrier protection for a surgical gown per ANSU AAMI 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.
Disposable Surgical Gown
This document is a 510(k) clearance letter for a Disposable Surgical Gown. It is a regulatory document addressing the substantial equivalence of the device to a predicate device, not a study report for a medical AI/ML device.
Therefore, the requested information about acceptance criteria, study details, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth, and training set details for an AI/ML device is not applicable to this document.
The document discusses:
- The device name: Disposable Surgical Gown
- Regulation Number: 21 CFR 878.4040
- Regulatory Class: Class II
- Product Code: FYA
- Indications for Use: "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 material. This surgical gown meets the requirements of AAMI Level 3/Level 4 barrier protection for a surgical gown per ANSU AAMI 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 acceptance criteria mentioned for the surgical gown are related to its physical performance as a barrier: "meets the requirements of AAMI Level 3/Level 4 barrier protection for a surgical gown per ANSU AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70)." However, this document does not provide a study detailing how these criteria were met or the specific results.
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(170 days)
Disposable Surgical Gown (Level 3, MF2103 Series), Disposable Surgical Gown (Level 3, MF2104 Series),
Disposable Surgical Gown (Level 4, MF2105 Series)
Disposable Surgical Gown (Level 3, MF2103 Series)/ Disposable Surgical Gown (Level 3, MF2104 Series)/ Disposable Surgical Gown (Level 4, MF2105 Series) is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. It is single use, disposable and supplied sterile.
Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, MF2103 Series and MF2104 Series met the requirements for Level 3 classification, MF2105 Series met the requirements of Level 4 classification.
Not Found
This document is a 510(k) premarket notification from the FDA, specifically concerning the substantial equivalence determination for Disposable Surgical Gowns. It clarifies that the device is found substantially equivalent to legally marketed predicate devices.
However, the provided text does not contain any information about an AI/ML-based medical device, its acceptance criteria, or the study that proves it meets those criteria. The device in question is a physical product (surgical gowns), and the assessment is based on physical barrier performance standards (ANSI/AAMI PB70:2012), not on AI/ML algorithm performance.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, including details like:
- A table of acceptance criteria and the reported device performance: Not applicable as the "performance" here refers to physical barrier properties, not algorithmic output.
- Sample sizes used for the test set and the data provenance: Not applicable. Testing for surgical gowns involves physical property tests (e.g., liquid barrier, particulate material transfer), not data sets.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical product like a surgical gown is established by standardized physical testing methods, not expert consensus on data.
- Adjudication method: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This is relevant for AI-assisted image interpretation, not physical products.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable in the context of AI/ML. The "ground truth" for the gowns is their adherence to ANSI/AAMI PB70:2012 standards.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
The document focuses on the regulatory clearance for a medical device (surgical gowns) based on their physical barrier performance against industry standards, not on an AI/ML algorithm's diagnostic or analytical performance.
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(118 days)
Disposable Surgical Gowns (S,M,L,XL,XXL,XXXL)
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 Gowns have body, sleeve and belt are made of SMMS nonwoven material, and cuff is made of cotton. The Disposable Surgical Gowns are blue color, sterilized by ethylene oxide gas, single use and disposable medical device. The proposed device is available in S (115×140cm), M (120×150cm), L (130×160cm), XL (140×170cm), XXL (150×175cm), and XXXL (170×180cm).
This proposed device can meet the requirements for Level 3 per ANSI/AAMI PB70:2012.
This document is a 510(k) Premarket Notification from the FDA for Disposable Surgical Gowns. It details the device, its intended use, comparison to a predicate device, and results of non-clinical tests.
Here's the breakdown of the acceptance criteria and study information, based on your request, extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Item | Test Standard | Acceptance Criteria | Reported Device Performance (Result) |
|---|---|---|---|
| Seam strength (ASTM D1683M-17) | ASTM D1683M-17 | ≥30N (7lbf) per standard F2407-20 for level 3 | PASS (77.54 N) - Average result from 10 samples |
| Breaking strength (ASTM D5034-09) | ASTM D5034-09 (2017) | ≥30N (7lbf) per standard F2407-20 for level 3 | PASS (MD: 156.87N, CD: 125.20N) - Average result from 10 samples |
| Tear strength (ASTM D5587-15) | ASTM D5587: 2015(2019) | ≥10N | PASS (MD: 66.34N, CD: 38.44N) - Average result from 10 samples |
| Lint and other generation in the dry state (ISO 9073-10:2003(E)) | ISO 9073-10: 2003 | Log10(particle count) |
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(268 days)
Disposable Surgical Gown, Level 4; Disposable Surgical Gown, Level 3
The StringKing Disposable Surgical Gown is a sterile, single use surgical apparel intended to be worn by healthcare professionals to help protect both the patient and the healthcare worker from the transfer of microorganisms, body fluids and particulate matter. The StringKing Surgical Gowns meet Level 3 and Level 4 requirements of ANSI/AAMI PB 70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities.
The Disposable Surgical Gown consists of a multi-layer nonwoven spunbond-meltblownspunbond (SMS) polyolefin & Film Lamination in the critical zones and a single layer of lighter, more breathable nonwoven SMS polvolefin in the non-critical zones. The StringKing Disposable Surgical Gown is designed for easy donning and doffing with hook and loop neck tabs, belt ties, removable transfer accessory, and polyester wrist cuffs. The StringKing Disposable Surgical Gown is one gown design that meets both Level 4 requirements of AMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities. The gown will be marketed as a L3 gown as well as a L4 gown. The StringKing Disposable Surgical Gowns are single use, disposable medical devices that will be provided sterile.
Here's a breakdown of the requested information based on the provided text, focusing on the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Standard | Acceptance Criteria | Reported Device Performance | Pass/Fail |
|---|---|---|---|
| ANSI/AAMI PB70:2012 (Overall classification) | Meets Level 3 and Level 4 Liquid Barrier Requirements | Meets ANSI/AAMI PB 70:2012 Level 3 and Level 4 Liquid Barrier requirements | Pass |
| Water Resistance Hydrostatic Pressure Test - AATCC 127:2017 (cm) | $\ge$ 50 cm | All samples passed at $\ge$ 50 cm | Pass |
| Flammability of Clothing Textiles - 16 CFR Part 1610 (a) | Class 1: $\ge$ 3.5 seconds | All samples passed at $\ge$ 3.5 seconds | Pass |
| Durability ASTM D-5034 | $\ge$ 7 lbf | All samples passed at greater than 7 lbf | Pass |
| Tensile Strength ASTM D-5034 Machine Direction and Cross Direction | $\ge$ 7 lbf | All samples passed at greater than 7 lbf | Pass |
| Trap Tear ASTM D5587-15 Machine Direction and Cross Direction | $\ge$ 2.3 lbf | All samples passed at $\ge$ 2.3 lbf | Pass |
| Water Resistance Impact Penetration Test AATCC 42 | $\le$ 1.0 g | All samples passed at $\le$ 1.0 g | Pass |
| ASTM D1683 Seam Strength | $\ge$ 7 lbf | All samples passed at $\ge$ 7 lbf | Pass |
| ASTM F1671 Viral Penetration | Level 4: No penetration at 2 psi | All samples showed no penetration at 2 psi | Pass |
| Ethylene oxide residuals ISO 10993-7 | EO |
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(567 days)
Disposable Surgical Gown Rk-3011C
The Disposable Surgical Gown Rk-3011C is 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.
Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the Disposable Surgical Gown Rk-3011C surgical gowns met the requirements for Level 3 classification.
This is a single use, disposable device(s), provided non-sterile. The Surgical Gowns is to be sold to re-packager/re-labeler establishments for ethylene oxide (EtO) sterilization according to ISO 11135 prior to marketing to the end user.
The proposed surgical gown is a single use, disposable medical device provided as bulk, non-sterile items to repackagers/ relablers for further packaging and Ethylene Oxide (EO) sterilization.
The gown is manufactured with four layers: the inner and outer layers are made of spun-bond polypropylene and the middle layers are made of melt blown polypropylene. All gowns are reinforced with polypropylene and microporous reinforcement material. The proposed surgical gown is only available in the available sizes of the proposed surgical gown are M, L, XL, and XXL.
The cuffs are composed of cotton and terylene. The back is open with ties to secure the gown.
The provided text describes the acceptance criteria and the study results for a medical device, specifically a "Disposable Surgical Gown Rk-3011C".
Here's the requested information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance | Pass/Fail |
|---|---|---|
| Tensile Testing: ≥30N | Head To Toe Peak Load (N) AVG: 138.8N, Cross Body AVG: 95.6N | Pass |
| Tearing Strength of Fabrics: ≥10N | HEAD TO TOE AVG: 57.3N, CROSS BODY AVG: 37.5N | Pass |
| Seam Strength: ≥30N | Min 59.0N | Pass |
| Water Resistance (Spray Impact Water): 50cmH2O) | Pass | |
| Determining Lint: |
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(107 days)
Disposable Surgical Gown (G4003)
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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(99 days)
Disposable Surgical Gown UM-148
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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(105 days)
Disposable Surgical Gown
Disposable Surgical Gown is 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. In addition, this surgical gown meets the requirements of AAMI Level 4 barrier protection for a surgical gown per ANSU AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities. It is single use, disposable medical devices, provided sterile.
The subject devices 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 materials.
In addition, this surgical gown meets the requirements of AAMI Level 4 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.
The proposed device is single use, disposable medical devices and provided sterile.
The main materials of device are SMS nonwoven +TPU membrane, PP and Polyester fiber, and the main manufacturing technique are Ultrasonic welding and Sewing.
The provided text is a 510(k) Summary for a medical device (Disposable Surgical Gown) and does not describe an AI/ML-driven device or study. Therefore, most of the requested information regarding acceptance criteria, training/test sets, ground truth establishment, expert adjudication, or MRMC studies for an AI/ML device is not applicable.
Instead, the document details the device's physical properties, material composition, and performance against established industry standards for surgical gowns. The "study" mentioned is a series of non-clinical tests to verify the device meets design specifications and relevant standards.
Here's a breakdown of the relevant information from the document, tailored to the non-AI/ML context:
Device Description: Disposable Surgical Gown
Purpose of the "Study" (Non-Clinical Testing): To verify that the proposed device (Disposable Surgical Gown) meets all design specifications and complies with relevant standards for surgical gowns, demonstrating its safety and effectiveness compared to a legally marketed predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
The document provides a table of non-clinical tests conducted, their purpose, acceptance criteria, and results.
| Test Method | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| AATCC 127 | Water resistance Hydrostatic Pressure | >50 cm | Passed |
| AATCC 42 | Water Resistance impact penetration Nonwoven and plastic Barriers | ≤1.0 g | Passed |
| ASTM D5034-09 | Tensile Strength | MD Mean≥30 lbs; CD Mean≥25 lbs | Passed |
| ASTM D5587-19 | Tearing Strength | MD Mean≥9 lbs; CD Mean≥18 lbs | Passed |
| ASTM F1868-17 | Evaporative Resistance of fabrics | Mean Evaporative Resistance (Ref)≥0.06(kPa·m2/W). | Passed |
| 16 CFR 1610 | Flammability testing | Meets requirements of Flame Resistant CPSC 1610 Class 1 | Meets requirements |
| ASTM D1683-17 | Seam Strength | >50N | Passed |
| ASTM F1671 | Resistance to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage | No virus through, “None Seen” | Passed |
| ISO 9073-10:2003 | Lint and Other particles generation in the dry state | Log 10 | Bacterial Endotoxin Test |
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(148 days)
Disposable Surgical Gown
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 proposed device is a poly-reinforced surgical gown, the critical zone is front chest and sleeves. The critical zone is reinforced with PP/PE composite breathable film. The proposed device is available in four different sizes, include M, L, XL,TL. The proposed devices can meet the requirements for Level 3 per ANSVAAMI PB70:2012. The proposed devices are disposable medical devices and provided sterile.
The document is a 510(k) Premarket Notification from the FDA regarding a Disposable Surgical Gown. It outlines the device's technical specifications and compares it to a predicate device. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to non-clinical performance and safety testing required for regulatory clearance, not studies involving AI or human reader performance as one might expect for a diagnostic AI device.
Here's an analysis based on the provided document:
This document describes the testing for a Disposable Surgical Gown, which is a physical medical device, not a diagnostic AI/algorithm. Therefore, concepts like "MRMC comparative effectiveness study," "standalone algorithm performance," "human readers improve with AI," "number of experts for ground truth," "adjudication method," and "training set size/ground truth establishment" are not applicable to this type of medical device submission. The "acceptance criteria" relate to physical and biological performance characteristics of the gown.
Non-Clinical Performance and Safety Testing for Disposable Surgical Gown
1. A table of acceptance criteria and the reported device performance:
| Test Methodology | Test Methodology Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| AAMI/ANSI PB70:2012 (Liquid Barrier) | Determine classification of subject surgical gown product. | N/A (classification level) | PASS (Level 3) |
| ASTM D5587-15 (Tearing Strength) | Evaluate tearing strength. | >30N | PASS (72/59N average from 3 nonconsecutive batches) |
| ASTM D5034-21 (Breaking Strength) | Evaluate breaking strength. | >10N | PASS (99/81N average from 3 nonconsecutive batches) |
| ASTM D1683M-17 (Seam Strength) | Evaluate failure in sewn seams. | >30N | PASS (Sleeve: 68.3N, Side: 69.7N, Belt: 71N average from 3 nonconsecutive batches) |
| AATCC 42-2013 (Water Impact) | Evaluate water impact. | ≤1.0 g | PASS (0~0.019 g average from 3 nonconsecutive batches) |
| ASTM F1868-17 (Evaporative Resistance) | Evaluate evaporative resistance. | 50 cm | PASS (52~290 cm average from 3 nonconsecutive batches) |
| CPSC 16 CFR Part 1610-2008 (Flammability) | Evaluate flammability. | Meets Class I requirements | PASS (Class I average from 3 nonconsecutive batches) |
| ISO 9073-10:2003(E) (Linting) | Evaluate lint and other particles generation. | Log10(particle count) |
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(95 days)
Disposable Surgical Gown, Disposable Reinforced Surgical Gown
Disposable Surgical Gown and Disposable Reinforced Surgical Gown 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. Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, Disposable Surgical Gown ML515M45U met the requirements for Level 3 classification, Disposable Surgical Gown GD524ME65 and Disposable Reinforced Surgical Gown met the requirements of Level 4 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 two types of surgical gown: Disposable Surgical Gown and Disposable Reinforced Surgical Gown. And each type of surgical gown is available in six product sizes, including S, M, L, XL, XXL and XXXL. Disposable Surgical Gown have two models: ML515M45U and GD524ME65. Disposable Reinforced Surgical Gown have one model: PA528ME45R. Disposable Surgical Gown ML515M45U met the requirements for Level 3 classification, Disposable Surgical Gown GD524ME65 and Disposable Reinforced Surgical Gown met the requirements of Level 4 classification.
The provided FDA 510(k) summary document (K212869) pertains to Disposable Surgical Gowns. This document describes the acceptance criteria and the study that proves the device meets those criteria, specifically through non-clinical performance testing and biocompatibility assessment rather than studies involving AI algorithms or human readers.
Therefore, many of the requested points regarding AI/human reader studies, ground truth establishment for such studies, and multi-reader multi-case analyses are not applicable to this submission.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document provides extensive tables (Table 3 and Table 4) detailing the acceptance criteria and results for various non-clinical performance and biocompatibility tests.
Table 1: Summary of Performance Testing - Categorized for clarity
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Flammability | Evaluate flammability of the test sample. | Meets Class 1 requirements | Pass |
| Hydrostatic Pressure | Determine hydrostatic pressure. | >50 cm | Level 3 Standard Surgical Gown: Average 67cm; Level 4 Standard Surgical Gown: Average 196cm; Level 4 Reinforced Surgical Gown: Average 162cm |
| Water Impact | Determine hydrostatic pressure. (Note: Description seems to be a typo, likely measuring water penetration/impact resistance) | ≤1.0 g | Level 3 Standard Surgical Gown: Average 0.011g; Level 4 Standard Surgical Gown: Average 0.014g; Level 4 Reinforced Surgical Gown: Average 0.017g |
| Breaking Strength | Evaluate breaking strength. | >20N | Level 3 Standard Surgical Gown: Lat. Avg 96N, Long. Avg 116N; Level 4 Standard Surgical Gown: Lat. Avg 111N, Long. Avg 184N; Level 4 Reinforced Surgical Gown: Lat. Avg 109N, Long. Avg 122N |
| Tearing Strength | Evaluate tearing strength. | >20N | Level 3 Standard Surgical Gown: Lat. Avg 77N, Long. Avg 128N; Level 4 Standard Surgical Gown: Lat. Avg 90N, Long. Avg 137N; Level 4 Reinforced Surgical Gown: Lat. Avg 80N, Long. Avg 137N |
| Linting | Evaluate linting. | Log10(particle count) 30 ft³/min/ft² | Level 3 Standard Surgical Gown: Average 40 ft³/min/ft² (Note: Only Level 3 reported, but acceptance criteria imply all gowns with this spec meet it) |
| EO/ECH Residue | Evaluate level of sterilant residues. | EO: |
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