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510(k) Data Aggregation
(79 days)
This non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
The subject device in this 510(k) Notification is Iconic Latex Glove - Powder Free Latex Examination Glove. The subject device is a patient examination glove made from Latex compound, Natural White color, powder free and non-sterile (Per 21 CFR 880.6250 - class I). The device meets the specifications in ASTM D3578-19 Standard specification for Rubber Examination Gloves. The available sizes of the subject devices are Small, Medium, Large, X-Larqe.
The information provided describes the acceptance criteria and the study conducted for the Iconic Latex Glove, a non-powdered patient examination glove.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Characteristics / Test Methodology | Acceptance Criteria (from Section 4.0 and 7.0) | Reported Device Performance (Average Results from Section 8.0) | Final Results (from Section 8.0) |
|---|---|---|---|
| Product Code | LYY | LYY | same |
| Intended Use | A powder-free patient examination glove, disposable, for medical purposes, worn on examiner's hand to prevent contamination between patient and examiner. For over-the-counter use. | This powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. The device is for over-the-counter use. | same |
| Material Used | Latex - Natural Rubber | Latex - Natural Rubber | same |
| Color | N/A (Predicate: Natural White) | Natural White | same |
| Sterility | Sterile/Non-sterile | Non sterile | - (Not explicitly "same", but matches expectation) |
| Single Use | Single use | Single use | same |
| Freedom from pinholes (ASTM D5151-19) | AQL 2.5 Inspection Level G-1 | Pass (across all sizes) | Pass |
| Overall Length (ASTM D3578-19) | Min 230mm | Small: 230.8mm, Medium: 240.5mm, Large: 237.5mm, X-Large: 236.8mm | Pass |
| Width (ASTM D3578-19) | Small - 80mm (±10mm); Medium - 95mm (±10mm); Large - 110mm (±10mm); X-Large - 120mm (±10mm) (Note: Table in 4.0 has typo for Large - 110 vs table in 7.0/8.0 as 111) | Small: 83mm, Medium: 96mm, Large: 108.4mm, X-Large: 118.7mm | Pass |
| Thickness at Palm (ASTM D3578-19) | Min 0.05 mm (from Section 4.0) Min: 0.08 mm (from Section 7.0/8.0) | 0.14mm (Small), 0.13mm (Medium), 0.12mm (Large), 0.14mm (X-Large) | Pass |
| Thickness at Fingertip (ASTM D3578-19) | Min 0.05 mm (from Section 4.0) Min: 0.08 mm (from Section 7.0/8.0) | 0.10mm (Small), 0.10mm (Medium), 0.09mm (Large), 0.14mm (X-Large) | Pass |
| Physical Properties Before Aging (ASTM D3578-19) | Tensile Strength = 18 MPa, min.; Ultimate Elongation = 650 % min | Tensile Strength: 20.8 (S), 23.4 (M), 21.4 (L), 20.7 (XL); Ultimate Elongation: 1018.7 (S), 878.9 (M), 1127.9 (L), 1097.6 (XL) | Pass |
| Stress at 500% Elongation (Before Aging) | N/A (Standard specifies min tensile and ultimate elongation) | 3.3 (S), 3.9 (M), 3.7 (L), 3.3 (XL) | Pass |
| Physical Properties After Accelerated Aging (ASTM D3578-19) | Tensile Strength = 14 MPa, min.; Ultimate Elongation = 500 % min | Tensile Strength: 15.3 (S), 17.3 (M), 16.9 (L), 17.4 (XL); Ultimate Elongation: 856.4 (S), 890.8 (M), 1077.3 (L), 956.8 (XL) | Pass |
| Residual Powder (ASTM D6124-06) | < 2.0 mg/pc | 0.12 (S), 0.26 (M), 0.38 (L), 0.18 (XL) | Pass |
| Extractable Protein (ASTM D5712-15) | Maximum 50 µg/dm² | Small = 10.3 µg/dm², Medium = 8.7 µg/dm², Large = 9.6 µg/dm², X-Large = 8.8 µg/dm² | Pass |
| In vitro cytotoxicity (ISO 10993-5) | Complies with the requirement of this standard | Complies with the requirement of this standard | Pass |
| Skin sensitization (ISO 10993-10) | Non-Sensitizer | Under the conditions of this study, the test article was a non-sensitizer (also stated as "Non - Skin Sensitized") | Pass |
| Systemic toxicity (ISO 10993-11) | Not induce systemic toxicity | Not induce systemic toxicity | Pass |
| Irritation (ISO 10993-23) | Non-irritant | Under the conditions of this study, the test article was a non-irritant (also stated as "Non-Irritant") | Pass |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for each individual test (e.g., number of gloves tested for pinholes, physical properties, etc.). It only provides the average results for different glove sizes (Small, Medium, Large, X-Large). The data provenance is not explicitly stated beyond the fact that the tests were conducted by a company in Malaysia (Iconic Medicare Sdn Bhd is in Malaysia, and the general testing information implies this is where their reports originated). These appear to be retrospective tests conducted on manufactured batches of the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as the device is a medical glove, and the "ground truth" is established through standardized laboratory testing against international and national standards (ASTM, ISO). There are no "experts" in the sense of clinicians or radiologists establishing ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods like "2+1" or "3+1" are typically used for interpreting results (e.g., medical images) where human judgment is involved in establishing a diagnosis or reading. The tests performed for this device are objective measurements against defined acceptance criteria in laboratory settings.
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 is not applicable. The device is a medical glove, not an AI-powered diagnostic or assistive tool. MRMC studies are used to evaluate diagnostic performance with and without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. The device is a medical glove, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established by objective measurements and results from standardized laboratory tests according to recognized national and international standards (ASTM D3578-19, ASTM D5151-19, ASTM D6124-06, ASTM D5712 -15, ISO 10993-5:2009, ISO 10993-10:2021, ISO 10993-11:2017, ISO 10993-23:2021).
8. The sample size for the training set
This is not applicable. The device is a physical product (a glove), not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
This is not applicable (see point 8).
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