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The Disposable nitrile gloves are disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.

The proposed device is Powder Free Disposable nitrile gloves. The proposed device is blue. The design of proposed device is addressing the standards as ASTM D6124,ASTM D5151, and ASTM D6319. The proposed device is non-sterile.

The provided document describes the non-clinical performance testing for "Disposable Nitrile Gloves" (K212009) to demonstrate substantial equivalence to a predicate device (K171422).

Here's the breakdown of the acceptance criteria and the study results:

1. Table of Acceptance Criteria and Reported Device Performance

| No. | Test Methodology / Standard | Purpose | Acceptance Criteria | Reported Device Performance (Results) |
|-----|-------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-
| 1 | ISO 10993-10:2010 (Skin Sensitization Test) | Assesses possible contact hazards from chemicals released from medical devices, that may produce skin sensitization. | Grades less than 1, otherwise sensitization. | All grades are 0. All animals survived and no abnormal signs were observed. |
| 2 | ISO 10993-10:2010 (Skin Irritation Test) | Assesses possible contact hazards from chemicals released from medical devices, that may produce skin irritation. | Primary irritation index of 0-0.4 for negligence. | Primary irritation index is 0. The response of the proposed device was categorized as negligible. |
| 3 | ISO 10993-5:2009 (Cytotoxicity) | Assesses the in vitro cytotoxicity of medical devices. | Viability percentage (Viab.%) of the 100% extract of the test article is the final result. If viability is reduced to <70% of the blank, it has cytotoxic potential. | Viab.% of 100% test article extract is 71.75%. This means the proposed device has no potential toxicity to L-929 in the MTT method. |
| 4 | ASTM D6124-06 (Reapproved 2017) (Residual Powder on Medical Gloves) | Designed to determine the amount of residual powder (or filter-retained mass) found on medical gloves. | Powder residue limit of 2.0 mg/glove. | 0.06 mg/glove. |
| 5 | ASTM D5151-06 (Reapproved 2015) (Detection of Holes) | Covers the detection of holes in medical gloves. | Sample number: 125 gloves. AQL: 2.5 (ISO 2859). Criterion ≤ 7 gloves for water leakage. | No glove water leakage found. |
| 6 | ASTM D6319-10 (Reapproved 2015) (Nitrile Examination Gloves) | Covers certain requirements for nitrile rubber gloves used in medical examinations and diagnostic and therapeutic procedures. | Freedom from holes: Refer to No. 5. Dimensions: S: width 80±10mm, Length ≥220 mm; M: width 95±10mm, Length ≥230 mm; L: width 110±10mm, Length ≥230 mm; XL: width 120±10mm, Length ≥230 mm. Thickness: Finger ≥0.05 mm, Palm ≥0.05 mm. Physical properties (Before Aging): Tensile strength ≥14MPa, Ultimate Elongation ≥500%. Physical properties (After Accelerated Aging): Tensile strength ≥14MPa, Ultimate Elongation ≥400%. | Dimensions: S: width: 82-86 mm, Length 238-245 mm; M: width 97-99 mm, Length 243-249 mm; L: width 108-111 mm, Length 244-254 mm; XL: width 115-118 mm, Length 237-246 mm. Thickness: Finger 0.13-0.15 mm, Palm 0.08 mm. Physical properties (Before Aging): Tensile strength 14.12-22.10 MPa, Ultimate Elongation 537.05%-907.44%. Physical properties (After Accelerated Aging): Tensile strength 14.46-20.20 MPa, Ultimate Elongation 542.91%-856.03%. |

2. Sample Size Used for the Test Set and Data Provenance

• Sample Sizes:

  • Skin Sensitization, Skin Irritation, and Cytotoxicity: The document states "All grades are 0. All animals were survived and no abnormal signs were observed during the study." for sensitization, and "The primary irritation index is 0." for irritation, and "Viab.% of 100% test article extract is 71.75%" for cytotoxicity. While it indicates successful testing, the specific numerical sample size for these biological evaluation tests (e.g., number of animals or cell cultures) is not explicitly provided in the summary.
  • Freedom from Holes (ASTM D5151-06): 125 gloves.
  • Residual Powder (ASTM D6124-06): Not specified, but implied to be sufficient for a quantitative measurement (0.06 mg/glove).
  • Dimensions and Physical Properties (ASTM D6319-10): Specific sample sizes for each dimension, thickness, and physical property measurement are not provided in this summary, but the results for ranges are given.

• Data Provenance: The document does not explicitly state the country of origin or whether the studies were retrospective or prospective. Given that this is a 510(k) summary for a Chinese manufacturer (JIANGSU SHENGLIJIE SAFETY PRODUCTS CO.,LTD), it is highly probable that the testing was conducted in China. These types of performance studies are typically prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not applicable to this type of device and study. The ground truth for these tests (e.g., irritation index, viability percentage, presence of holes, tensile strength) is established by standardized laboratory procedures and measurements, not by expert consensus or interpretation of images.

4. Adjudication Method for the Test Set

This information is not applicable. As stated above, the "ground truth" for these performance tests is determined by objective, standardized measurements rather than human interpretation that would require adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret and a comparative effectiveness with and without AI assistance is measured. This document is for disposable nitrile gloves, which do not involve such a scenario.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a standalone (algorithm only) study was not done. This concept applies to AI/ML software as a medical device. Disposable nitrile gloves are a physical medical device, and their performance is evaluated through physical and biological testing, not through algorithms.

7. The Type of Ground Truth Used

The ground truth used for these tests is objective, standardized measurements and laboratory observations according to established international and national standards (ISO 10993, ASTM D6124, ASTM D5151, ASTM D6319). This includes:

• Quantitative measurements (e.g., primary irritation index, viability percentage, powder content, dimensions, tensile strength, elongation).
• Qualitative observations based on standardized protocols (e.g., presence/absence of abnormal signs for sensitization, water leakage for holes).

8. The Sample Size for the Training Set

Not applicable. This device (disposable nitrile gloves) does not utilize a training set in the context of machine learning or AI models. The testing described is for physical and biological performance, not for developing an algorithm.

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no training set for this device.

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