Search Results
Found 1 results
510(k) Data Aggregation
(156 days)
The Disposable Nitrile Examination Gloves is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
The proposed device is Powder Free Nitrile Examination 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.
This document is a 510(k) Premarket Notification for "Disposable Nitrile Examination Gloves" (K203436) by Shandong Zhushi Pharmaceutical Group Co., Ltd. The purpose of this submission is to demonstrate substantial equivalence to a legally marketed predicate device (K171422).
The 510(k) submission primarily relies on non-clinical performance testing to demonstrate safety and effectiveness.
Here's an analysis based on your request, focusing on acceptance criteria and study proving device meets criteria:
1. A table of acceptance criteria and the reported device performance
| No. | Test Methodology / Standard | Purpose | Acceptance Criteria | Reported Device Performance (Results) |
|---|---|---|---|---|
| 1 | ISO 10993-10:2010 (Skin Sensitization Test) | Assess possible contact hazards from chemicals, specifically skin sensitization. | Grades less than 1. | All grades are 0. All animals were survived and no abnormal signs were observed during the study. (Pass) |
| 2 | ISO 10993-10:2010 (Skin Irritation Test) | Assess possible contact hazards from chemicals, specifically skin irritation. | Primary irritation index is 0-0.4 for "Negligible" response category. | The primary irritation index is 0. The response of the proposed device was categorized as negligible under the test condition. (Pass) |
| 3 | ISO 10993-5:2009 (In Vitro Cytotoxicity) | Assess the in vitro cytotoxicity of medical devices. | Viability is not reduced to <70% of the blank. | Viab.% of 100% test article extract is 70.9%. It means the proposed device has no potential toxicity to L-929 in the MTT method. (Pass) |
| 4 | ASTM D6124-06 (Reapproved 2017), Standard Test Method for Residual Powder on Medical Gloves | Determine the amount of residual powder found on medical gloves. | Powder residue limit of 2.0 mg. | 0.02 mg (Pass, well below the limit) |
| 5 | ASTM D5151-06 (Reapproved 2015), Standard Test Method for Detection of Holes in Medical Gloves. | Covers the detection of holes in medical gloves. | Samples number: 125 gloves; AQL: 2.5 (ISO 2859); Criterion ≤7 gloves for water leakage. | No glove water leakage found. (Pass) |
| 6 | ASTM D6319-10 (Reapproved 2015), Standard Specification For Nitrile Examination Gloves For Medical Application. | Covers certain requirements for nitrile rubber gloves used in medical examinations and diagnostic/therapeutic procedures. | Dimensions: - XS: width 70±10mm, length ≥220 mm - S: width 80±10mm, length ≥220 mm - M: width 95±10mm, length ≥230 mm - L: width 110±10mm, length ≥220 mm - XL: width 75±6mm, length ≥220 mm - Thickness (Finger & 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: - XS: Avg width 71.38 mm, Avg Length 221.25 mm. Avg Finger thickness 0.05 mm, Avg Palm thickness 0.07 mm. - S: Avg width 82.63 mm, Avg Length 221.12 mm. Avg Finger thickness 0.055 mm, Avg Palm thickness 0.066 mm. - M: Avg width 93.4 mm, Avg Length 232.13 mm. Avg Finger thickness 0.053 mm, Avg Palm thickness 0.079 mm. - L: Avg width 102.75mm, Avg Length 231.4 mm. Avg Finger thickness 0.054 mm, Avg Palm thickness 0.076 mm. - XL: Avg width 115.4mm, Avg Length 231.7 mm. Avg Finger thickness ≥0.054 mm, Avg Palm thickness ≥0.08 mm. Physical Properties (Before Aging): - Avg Tensile strength 25.4 MPa - Avg Ultimate Elongation ≥608% Physical Properties (After Accelerated Aging): - Avg Tensile strength 25MPa - Avg Ultimate Elongation 505% (All dimensions and physical properties meet or exceed the specified criteria. Sterility is N.A. (not applicable as it's non-sterile), and Freedom from Holes and Powder-free Residue refer to tests #5 and #4 respectively, which passed). |
2. Sample sizes used for the test set and the data provenance
- ISO 10993-10 (Skin Sensitization & Irritation): The document doesn't explicitly state the exact sample size (number of animals) used for the biological evaluation tests beyond stating "All animals were survived" and "the primary irritation index is 0". Typically, these standards specify minimum animal counts.
- ISO 10993-5 (In Vitro Cytotoxicity): "Viab.% of 100% test article extract is 70.9%". This refers to cell culture tests (L-929 cells). The exact number of replicates or passages is not specified.
- ASTM D5151 (Freedom from Holes): Sample size: 125 gloves.
- ASTM D6124 (Residual Powder) & ASTM D6319 (Dimensions, Physical Properties): The sample sizes for these physical and chemical tests are not explicitly stated in the document, but they are typically governed by the respective ASTM standards (e.g., a certain number of gloves per batch/size for dimensional checks or tensile strength tests).
- Data Provenance: The document does not explicitly state the country of origin for the test data generation. However, the submitter is "Shandong Zhushi Pharmaceutical Group Co., Ltd" from "Shandong, China" and the designated submission correspondent is in "Shanghai, China." Given this information, it is highly likely that the testing was conducted in China. The data would be considered prospective as it was generated specifically for this 510(k) submission to demonstrate compliance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable as this is a submission for a Class I medical device (Disposable Nitrile Examination Gloves), which primarily relies on engineering and material performance standards. It is not an AI/imaging device requiring expert interpretation for ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable. Adjudication methods are relevant for studies involving human interpretation of data, typically in diagnostic imaging or clinical trials, not for physical performance testing of gloves.
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 section is not applicable. This is not an AI-assisted diagnostic device, and no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. This is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance of these gloves is established through direct physical, chemical, and biological testing against established scientific standards (ISO and ASTM). For example:
- Physical Properties (Tensile Strength, Elongation, Dimensions): The ground truth is the measured physical characteristic of the glove compared against the specified numerical limits in ASTM D6319.
- Freedom from Holes: The ground truth is the absence or presence of water leakage as per ASTM D5151.
- Residual Powder: The ground truth is the measured powder amount compared against the limit in ASTM D6124.
- Biocompatibility (Irritation, Sensitization, Cytotoxicity): The ground truth is the biological response observed in the in-vitro or in-vivo (animal) models according to ISO 10993 standards, compared against defined non-toxic or non-irritant criteria.
8. The sample size for the training set
This section is not applicable. There is no "training set" for this device as it is not a machine learning or AI-based product.
9. How the ground truth for the training set was established
This section is not applicable. As there is no training set.
Ask a specific question about this device
Page 1 of 1