(105 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
White Nitrile Powder Free Patient Examination Glove, Non-Sterile meet all requirements of ASTM standard D6319 and FDA 21 CFR 880.6250. The powder free nitrile examination glove is manufactured from synthetic rubber latex. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e., can be worn on right hand or left hand.
The provided text describes the acceptance criteria and performance of the White Nitrile Powder Free Patient Examination Glove, Non-Sterile (K210775).
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Standard/Test Method | Acceptance Criteria | Reported Device Performance (Current White) | Comparison Analysis |
|---|---|---|---|---|
| Manufacturer(s) | - | - | Onetexx Sdn Bhd | Same |
| Material | ASTM D6319 | Nitrile | Nitrile | Same |
| Color | - | White | White | Same |
| Physical Properties | ||||
| Before Aging | ASTM D412 | Tensile Strength: Min 14.0 MPa | ||
| Ultimate Elongation: Min 500% | Tensile Strength: 32.35 MPa | |||
| Ultimate Elongation: 568% | Different but within the ASTM standard | |||
| After Aging | ASTM D412 | Tensile Strength: Min 14.0 MPa | ||
| Ultimate Elongation: Min 400% | Tensile Strength: 36.10 MPa | |||
| Ultimate Elongation: 551% | Different but within the ASTM standard | |||
| Thickness (Finger) | ASTM D3767 | Min 0.05 mm | 0.10 mm | Different but within the ASTM standard |
| Thickness (Palm) | ASTM D3767 | Min 0.05 mm | 0.07 mm | Different but within the ASTM standard |
| Powder Free | ASTM D6124 | Less than 2 mg per glove | 0.24 mg/glove | Different but within the ASTM standard |
| Biocompatibility | ||||
| Primary Skin Irritation | ISO 10993-10:2010 (E) & Consumer Product Safety Commission Title 16, Chapter II, Part 1500 | Non-irritant or non-sensitizer | The test material did not cause an irritant response. The Primary Irritant Response Category is deemed 'Negligible'. | Similar |
| Dermal Sensitization | ISO 10993-10: 2010 (E) & Consumer Product Safety Commission, Title 16, Chapter II, Part 1500.3 (c) (4) | Non-irritant or non-sensitizer | The test material did not produce a skin sensitization effect in the guinea pigs. | Similar |
| Cytotoxicity - MEM Elution | ISO 10993-5: 2009 (E) | (Predicate: Not Tested) | The test material demonstrated a cytotoxic effect under the condition of this study. Additional test i.e. Acute Systemic Toxicity was tested. | Different |
| Acute Systemic Toxicity | ISO 10993-11: 2017 (E) | (Predicate: Not Tested) | The test item did not induce any systemic toxicity. | Different |
| Watertight | ASTM D5151:2019 | Sample size: 500 pcs, Inspection level: G1, AQL: 1.5, Acceptance No. 10 (or equivalent based on batch size for sampling plan) | Batch size 150,001 to 500,000, sample drawn: 315 pieces, accept: 10, reject: 11. 1 piece found with leaks. Falls within acceptance criteria. Gloves passed AQL 1.5. | Similar |
| Dimension (Length) | ASTM D3767 | Min 240 mm | XS: 250mm, S: 250mm, M: 249mm, L: 249mm, XL: 250mm | Pass |
| Dimension (Width) | ASTM D3767 | X-Small - 70 ± 10 mm, Small - 80 ± 10 mm, Medium - 95 ± 10 mm, Large - 110 ± 10 mm, X-Large – 120 ± 10 mm | XS: 78mm, S: 87mm, M: 98mm, L: 107mm, XL: 118mm | Pass |
| Intended use | - | Disposable device for medical purposes, worn on hand/finger to prevent contamination. | A patient examination glove is a disposable device made of synthetic rubber latex intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. | Same |
| Size | Medical Glove Guidance Manual - Labeling | Small, Medium, Large, X Large (Predicate) | Extra Small, Small, Medium, Large, Extra Large | Similar |
| Single use | Medical Glove Guidance Manual - Labeling | Single Patient Use (Predicate) | Single Use | Same |
2. Sample size used for the test set and the data provenance
- Physical Properties (Tensile Strength, Ultimate Elongation_): No specific sample size for a test set is provided beyond the general understanding that testing was conducted per ASTM D412. The results are reported as single values (e.g., 32.35 MPa), implying these are average or representative values from tests.
- Dimension: Not explicitly stated, but measurements for XS, S, M, L, XL sizes are provided.
- Watertight:
- Sample Size: A batch size of 150,001 to 500,000 gloves was considered for sampling.
- Actual Sample Drawn: 315 pieces as per single sampling plan GI for AQL 1.5.
- Residual Powder:
- Sample Size: 5 pieces.
- Biocompatibility:
- Specific sample sizes for Primary Skin Irritation, Dermal Sensitization, Cytotoxicity, and Acute Systemic Toxicity are not provided in the summary but typically involve animal testing (e.g., guinea pigs for sensitization).
Data Provenance: Not explicitly stated, but the testing would have been conducted by Onetexx Sdn Bhd (the submitter) or a contracted lab to meet the specified ASTM and ISO standards. Given the manufacturer's address in Malaysia, it is likely the testing was conducted in Malaysia or a recognized testing facility accessible to them. The studies are non-clinical (device performance tests).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This submission pertains to physical and biocompatibility testing of a medical glove, which relies on standardized objective test methods (ASTM, ISO) rather than expert consensus on interpretation. The "ground truth" is defined by the acceptance criteria set forth in these standards.
4. Adjudication method for the test set
Not applicable. The tests are objective measurements against established technical standards, not subjective interpretations requiring adjudication.
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
Not applicable. This is a submission for a patient examination glove, not an AI-powered diagnostic or assistive device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is for a physical medical device (glove), not a software or algorithm.
7. The type of ground truth used
The "ground truth" for the device's performance is based on objective measurements and adherence to established industry standards (ASTM, ISO) and regulatory requirements (21 CFR 880.6250). For example:
- Physical properties (tensile strength, elongation, thickness) are measured against numerical thresholds defined by ASTM D412 and ASTM D3767.
- Watertight integrity is assessed against the Acceptance Quality Limit (AQL) defined by ASTM D5151.
- Residual powder is measured against a quantitative limit in ASTM D6124.
- Biocompatibility (skin irritation, sensitization, cytotoxicity, systemic toxicity) is evaluated based on the criteria specified in ISO 10993 series, which typically involve observing biological responses in test models and determining if they meet "non-irritant," "non-sensitizer," or "no systemic toxicity" classifications.
8. The sample size for the training set
Not applicable. There is no "training set" as this is not a machine learning or AI device.
9. How the ground truth for the training set was established
Not applicable. There is no "training set" for this type of device.
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.