Search Results

The CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown (Model number: IL4036YKTP-L4) is intended to provide barrier protection and protect healthcare personnel and patients from the transfer of microorganisms, body fluids and particulate material. CoverU Disposable Gown with Tape meets the requirements of AAMI Level 4 barrier protection for a surgical isolation gown per ANSI/ AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities. Not intended for use in the operating room. CoverU Disposable Gown with Tapes is a single use, disposable medical device provided non-sterile.

The CoverU Disposable Gown with Tape - Chemo Gown (Model number IL-4036YKTP-CM) is intended to provide barrier protection and protect healthcare personnel and patients from the transfer of microorganisms, body fluids and particulate material. CoverU Disposable Gown with Tape meets the requirements of AAMI Level 4 barrier protection for a surgical isolation gown per ANSI/ AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities. Not intended for use in the operating room. CoverU Disposable Gown with Tapes is a single use, disposable medical device provided non-sterile. The gowns have been evaluated for resistance to permeation of various chemotherapy drugs per ASTM F739-12, Standard Test Method for Permeation of Liquids and Gases Through Protective Clothing Materials Under Conditions of Continuous Contact. Chemotherapy drug permeation resistance, average standardized breakthrough time in minutes *:

Carmustine [3.3 mg/ml] >480 Cisplatin [1.0 mg/ml] >480 Cyclophosphamide [20 mg/ml] >480 Cytarabine Hydrochloride [100 mg/ml] >480 Dacarbazine [10 mg/ml] >480 Daunorubicin Hydrochloride [5 mg/ml] >480 Doxorubicin Hydrochloride [2 mg/ml] > 480 Etopside [20 mg/ml] >480 Fluorouracil [50 mg/ml] >480 lfosfamide [50 mg/ml] > 480 Methotrexate [25 mg/ml] >480 Mitomycin C [0.5 mg/ml] >480 Mitoxantrone [2.0 mg/ml] >480 Paclitaxel [6 mg/ml] >480 Thiotepa [10 mg/ml] >480 Vincristine Sulfate [1 mg/ml] >480 Docetaxel [10mg/ml] >480 Oxaliplatin [5mg/ml] >480 Leucovorin [10mg/ml] >480

*No permeation was detected at either the minimum detectable permeation or 0.1 ug/cm2/min

Device Description

The CoverU Disposable Gown with Tape is constructed of PPSB Coated PE materials with the color in yellow. It is sealed the seam by Adheresive tape provide protection from liquid borne. The sleeves of the gown have knit cuffs sewn onto the end of the sleeve at the user's wrists to keep the sleeves in place on the wearer. Tie at the neck and waist for secure protection AAMI level 4 standard provides high performance on hydrostatic pressure and fluids impact.

The CoverU Disposable Gown with Tape is sold in one size, non-sterile and is intended to be a single use, disposable device, and does NOT contain any drugs or biologics and not made with natural rubber latex. The two gown models are exact the same gowns, except the chemo-drug labeling claim. one is intended to protect workers from high fluid level (blood body fluids etc.) and blood borne pathogen, and the other is intended to protect healthcare personnel from exposure to chemotherapy drugs during preparation, handling, and administration. Ten (10) pieces of CoverU Disposable Gown with Tape are packaged in a plastic bag and ten bags are outer packaging with a paper carton box. These gowns are offered in a universal size.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device, specifically a disposable gown. The acceptance criteria and the proof of meeting those criteria are detailed in the non-clinical performance testing section.

Here's the breakdown of the information requested, based on the provided document:

1. A table of acceptance criteria and the reported device performance

Test Performed	Purpose	Test Method/Standard Followed	Acceptance Criteria	Test Result
Hydrostatic Pressure	To determine the hydrostatic pressure of the test sample.	ATCC 127/AAMI Standard PB70 Level 4	>50 cm H2O	Pass
Water Impact	To determine the Water impact of the test sample.	ATCC 42/AAMI Standard PB70 Level 4	<1.0 g	Pass
Resistance of Materials to Penetration by Viral	To measure blood-borne pathogens using a surrogate microbe under conditions of continuous liquid contact.	ASTM F1671/F1671M-13/ANSI/AAMI Standard PB70 Level 4	Penetration Does Not Appear	Pass
Basic Weight	To determine the Basic weight of the test article.	ASTM D3776 / D3776M (2020)	Avg. 40 g/m2 ±5%	Pass
Grab Tensile Strength	To evaluate the breaking strength of the test sample by test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test).	ASTM D5034-09(2017) /ASTM D5034-09(2017)	Tensile strength >=7 lbf (>=30N)	Pass
Seam Strength	To evaluate the seam strength of the test sample by the method of Failure in Sewn Seams of Woven Fabrics.	ASTM D1683 / D1683M - 17(2018)	Seam Strength in critical zone >=7 lbf (>=30N)	Pass
Trapezoid Test Tear Strength	To evaluate the tearing strength of the test sample.	ASTM D5733-99/ASTM D5733-99	Seam Strength in critical zone >=10N (>=2.3 lbf)	Pass
Flammability	To evaluate the flammability of the test sample in accordance with 16 CFR Part 1610 Standard for the Flammability of Clothing Textiles.	16 CFR Part 1610/ASTM F2407-06(2013) e1, Section 6.3 flame spread	Class 1 does not Ignite	Pass
Resistance to Linting of Nonwoven Fabrics (Dry)	To evaluate the linting of the test sample by the method of Nonwovens-Pat 10: Lint and Other Particles Generation in the Dry State.	EN ISO 9073-10:2004/EN 13795-1:2019	Requirement Coefficient of linting <=4.0	Pass
Resistance to permeation of chemotherapy drugs test	To measure the absorbance of test chemicals, which permeated through the specimens into the collection medium.	ASTM F739-12	Results showed no average standardized breakthrough for up to 480 minutes for claimed 15 drugs	Pass
Cytotoxicity	To evaluate the cytotoxicity of the test sample.	ISO10993-5	The averaged result concluded that the "Disposable Isolation Gown" extract did not induce cytotoxic to L929 cells.	Pass
Irritation	To evaluate the irritation of the test sample.	ISO10993-10	No erythema and no edema were observed on the skin of the rabbits. Furthermore, the PII values were 0.	Pass
Sensitization	To evaluate the sensitization of the test sample.	ISO10993-10	The submitted sample under the conditions of this study, the test article extract showed no evidence of causing delayed dermal contact sensitization in the guinea pig.	Pass

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document describes non-clinical performance testing of the device itself (materials, barrier properties, etc.). It does not refer to a "test set" in the context of clinical data or AI model evaluation. The tests performed are laboratory-based and measure physical and chemical properties of the gown.

Sample size: The document does not explicitly state the number of individual gown samples or material specimens tested for each criterion. It mentions "Avg. 40 g/m2 ±5%" for Basic Weight, which implies an average was taken from multiple measurements, but the N is not provided. For biocompatibility tests (cytotoxicity, irritation, sensitization), typical sample sizes are small (e.g., a few rabbits or cell culture replicates), but they are not specified here.
Data provenance: The testing was non-clinical (laboratory-based). The applicant company is MEDTECS (TAIWAN) CORP., suggesting the testing may have been conducted there or by a contracted lab. The document does not specify the country of origin of the testing data, nor does it refer to retrospective or prospective data as it's not a clinical study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable. The product is a physical medical device (gowns), not an AI/software device that requires expert-established ground truth from medical images or patient data. The "ground truth" for these tests is defined by established international standards (ASTM, AATCC, ISO, ANSI/AAMI, CPSC).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for establishing ground truth for diagnostic accuracy, often in imaging or pathology. These are not relevant to the physical and chemical performance testing of medical gowns.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This question is not applicable. The device is a medical gown, not an AI-assisted diagnostic tool. No MRMC study was conducted or is relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable. The device is a medical gown, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the performance of this device is based on established national and international consensus standards for barrier protection, material properties, flammability, and biocompatibility of protective apparel (e.g., ANSI/AAMI PB70:2012, ASTM F1671/F1671M-13, ISO 10993 series, etc.). These standards define the test methods and the acceptable performance thresholds.

8. The sample size for the training set

This question is not applicable. There is no AI model or "training set" for this device.

9. How the ground truth for the training set was established

This question is not applicable. There is no AI model or "training set" for this device.

Ask a Question

Ask a specific question about this device

Page 1 of 1