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510(k) Data Aggregation
(199 days)
The Patient Examination 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 a nitrile patient examination glove. The design of proposed device addresses the standard specification requirements of ASTM D6319-19. The proposed device is non-sterile and powder free, with fern green, midnight black and sky blue three colors.
The document provided describes the acceptance criteria and the results of non-clinical performance testing for "Patient Examination Gloves" (nitrile gloves) in support of a 510(k) submission (K230777).
Here's an analysis of the provided information, focusing on the requested aspects.
1. A table of acceptance criteria and the reported device performance
Please note that for multiple colors of gloves (Fern Green, Blue Sky, Midnight Black), the results were consistently reported and are summarized below for brevity where they pass the criteria. Where specific values for each color are provided and vary, they are listed.
Acceptance Criteria and Reported Device Performance
| No. | Name of the Test Methodology | Standard | Acceptance Criteria | Reported Device Performance and Remarks | Pass/Fail |
|---|---|---|---|---|---|
| 1 | Tests For Skin Sensitization | ISO 10993-10:2021 | Skin Sensitization Test: Grades less than 1, otherwise sensitization. | Fern Green, Blue Sky, Midnight Black: No sensitization response was observed in control and treatment group animals. Classified as "non-sensitizer". | Pass |
| 2 | Tests For Skin Irritation | ISO 10993-23:2021 | Skin Irritation Test: Primary irritation index 0-0.4 (Negligible), 0.5-1.9 (Slight), 2-4.9 (Moderate), 5-8 (Severe). (Implied goal is negligible or slight irritation). | Fern Green, Blue Sky, Midnight Black: No abnormality detected in animals. Classified as "non-irritant". | Pass |
| 3 | In Vitro Cytotoxicity | ISO 10993-5:2009 | Cell viability reduced to <70% of the blank indicates cytotoxic potential. | Fern Green, Blue Sky, Midnight Black: Cell viability post treatment with 25%, 50%, and 100% test item extracts observed was less than 70% when compared to the vehicle control at all concentrations except 12.5%. Hence, the test item extract was considered to be cytotoxic. (However, the device passed Acute Systemic Toxicity). | Fail |
| 4 | Systemic Toxicity | ISO 10993-11:2017 | No adverse systemic reactions. | Fern Green, Blue Sky, Midnight Black: No animal deaths or loss in body weight. Did not reveal systemic toxicity. | Pass |
| 5 | Residual Powder on Medical Gloves | ASTM D6124-06 (2022) | Powder residue limit of 2.0 mg/glove. | Fern Green: 0.6 mg/glove. Blue Sky: 0.9 mg/glove. Midnight Black: 0.8 mg/glove. | Pass |
| 6 | Detection of Holes in Medical Gloves | ASTM D5151-2006 | Freedom from holes, AQL: 2.5 (ISO 2859). | Fern Green, Blue Sky, Midnight Black: 0 Glove leakage. | Pass |
| 7 | Physical dimensions (Length) | ASTM D6319-19 | S: Length ≥ 220 mm; M: Length ≥ 230 mm; L: Length ≥ 230 mm; XL: Length ≥ 230 mm. | Fern Green: S: 241 mm, M: 253 mm, L: 255 mm, XL: 257 mm. Blue Sky: S: 242 mm, M: 251 mm, L: 254 mm, XL: 254 mm. Midnight Black: S: 240 mm, M: 253 mm, L: 254 mm, XL: 253 mm. (All pass) | Pass |
| Physical dimensions (Width) | ASTM D6319-19 | S: 80 ± 10 mm; M: 95 ± 10 mm; L: 110 ± 10 mm; XL: 120 ± 10 mm. | Fern Green: S: 85 mm, M: 97 mm, L: 110 mm, XL: 118 mm. Blue Sky: S: 82 mm, M: 97 mm, L: 111 mm, XL: 118 mm. Midnight Black: S: 84 mm, M: 98 mm, L: 109 mm, XL: 119 mm. (All pass) | Pass | |
| Thickness (Finger) | ASTM D3767-03 | Finger ≥ 0.05 mm. | Fern Green: 0.11 mm. Blue Sky: 0.09 mm. Midnight Black: 0.10 mm. (All pass) | Pass | |
| Thickness (Palm) | ASTM D3767-03 | Palm ≥ 0.05 mm. | Fern Green: 0.06 mm. Blue Sky: 0.08 mm. Midnight Black: 0.07 mm. (All pass) | Pass | |
| 8 | Physical properties: Before aging (Tensile Strength) | ASTM D412-16 | Tensile strength ≥ 14MPa. | Fern Green: 17.23 MPa. Blue Sky: 17.17 MPa. Midnight Black: 17.25 MPa. (All pass) | Pass |
| Physical properties: Before aging (Ultimate Elongation) | ASTM D412-16 | Ultimate Elongation ≥ 500%. | Fern Green: 540%. Blue Sky: 539%. Midnight Black: 541%. (All pass) | Pass | |
| 9 | Physical properties: After Accelerated Aging (Tensile Strength) | ASTM D412-16 | Tensile strength ≥ 14MPa. | Fern Green: 16.30 MPa. Blue Sky: 16.32 MPa. Midnight Black: 16.23 MPa. (All pass) | Pass |
| 10 | Physical properties: After Accelerated Aging (Ultimate Elongation) | ASTM D412-16 | Ultimate Elongation ≥ 400%. | Fern Green: 450%. Blue Sky: 449%. Midnight Black: 452%. (All pass) | Pass |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document extensively lists the accepted criteria for various tests, but it does not explicitly state the sample sizes used for each specific test in the provided tables. For example, for "Detection of Holes", it simply states "0 Glove leakage" without indicating how many gloves were tested to achieve this. Similarly, for biocompatibility tests, it reports results (e.g., "No sensitization response") but not the number of animals or cells used.
The data provenance (country of origin, retrospective/prospective) is also not specified in the provided text. The submission is from 3A Glove Sdn. Bhd. (Malaysia), with a designated correspondent in Shanghai, China, but this doesn't clarify where the tests themselves were conducted or the origin of the samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable as the document describes non-clinical performance testing for medical devices (gloves), not a diagnostic device or AI system that requires expert interpretation for establishing ground truth. The tests are based on objective physical, chemical, and biological measures against established standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable for the same reason as point 3. Adjudication methods are typically used in clinical studies or studies involving human interpretation of data where consensus among experts is needed.
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 information is not applicable as the document is for a medical device (patient examination gloves) and not an AI-assisted diagnostic device. No comparative effectiveness study with human readers or AI assistance was conducted or discussed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the device is a patient examination glove, not an algorithm or software. Therefore, there is no "standalone" algorithm performance to report.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the non-clinical performance tests is based on established objective measurements and standardized test methods as defined by recognized international and national standards (ISO, ASTM). For example:
- Biocompatibility: Adherence to biological response criteria in animal models (ISO 10993 series).
- Physical Properties: Measurement of dimensions, tensile strength, and elongation against specifications in ASTM standards (e.g., D6319, D412).
- Hole Detection: Compliance with acceptable quality levels (AQL) as per statistical sampling plans (ASTM D5151, ISO 2859).
- Powder Content: Direct measurement against a defined limit (ASTM D6124).
The acceptance criteria themselves serve as the "ground truth" that the device must meet.
8. The sample size for the training set
This information is not applicable. The device is a physical product (nitrile gloves), not an artificial intelligence or machine learning system that requires a "training set."
9. How the ground truth for the training set was established
This information is not applicable for the same reason as point 8. No training set or associated ground truth establishment is relevant to the conformity testing of patient examination gloves.
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