(119 days)
Blue Nitrile Examination Gloves Powder Free are disposable devices intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Blue Nitrile Examination Gloves Powder Free are equivalent to the Class I patient examination gloves bearing the product code LZA (21CFR880.6250). They meet all the current specifications listed under the ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application. They are made from Nitrile (NBR)100%. These gloves are blue in color and are powder free. The product is non-sterile, ambidextrous and single use only.
Blue Nitrile Examination Gloves Powder Free with sizes X-Small, Medium, Large and X-Large are included in the submission.
Here's a breakdown of the acceptance criteria and study information for the Blue Nitrile Examination Gloves Powder Free, based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic / Test Method | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimensions - Length (ASTM D6319-19) | Min 230 mm for all sizes | X-Small: 250 mm, Small: 241 mm, Medium: 240 mm, Large: 243 mm, X-Large: 240 mm (All > 230 mm) |
| Dimensions - Width (ASTM D6319-19) | X-Small: 70+/-10 mm, Small: 80+/-10 mm, Medium: 95+/-10 mm, Large: 110+/-10 mm, X-Large: 120+/-10 mm | X-Small: 80 mm, Small: 82 mm, Medium: 93 mm, Large: 103 mm, X-Large: 110 mm (All within specified ranges) |
| Physical Properties - Tensile Strength (Before Ageing) (ASTM D6319-19) | 14 MPa Min for all sizes | X-Small: 24.5 MPa, Small: 22.7 MPa, Medium: 25.3 MPa, Large: 26.4 MPa, X-Large: 25.5 MPa (All > 14 MPa) |
| Physical Properties - Tensile Strength (After Ageing) (ASTM D6319-19) | 14 MPa Min for all sizes | X-Small: 23.8 MPa, Small: 24.3 MPa, Medium: 31.9 MPa, Large: 30.3 MPa, X-Large: 27.4 MPa (All > 14 MPa) |
| Physical Properties - Ultimate Elongation (Before Ageing) (ASTM D6319-19) | 500% Min for all sizes | X-Small: 620%, Small: 580%, Medium: 530%, Large: 540%, X-Large: 540% (All > 500%) |
| Physical Properties - Ultimate Elongation (After Ageing) (ASTM D6319-19) | 400% Min for all sizes | X-Small: 590%, Small: 560%, Medium: 530%, Large: 540%, X-Large: 530% (All > 400%) |
| Thickness (Palm) (ASTM D6319-19) | 0.05 mm min for all sizes | X-Small: 0.101 mm, Small: 0.089 mm, Medium: 0.100 mm, Large: 0.098 mm, X-Large: 0.094 mm (All > 0.05 mm) |
| Thickness (Finger) (ASTM D6319-19) | 0.05 mm min for all sizes | X-Small: 0.121 mm, Small: 0.103 mm, Medium: 0.116 mm, Large: 0.121 mm, X-Large: 0.114 mm (All > 0.05 mm) |
| Powder Residue (ASTM D6124-06) | ≤ 2 mg/glove | X-Small: 1.07 mg/glove, Small: 1.49 mg/glove, Medium: 0.62 mg/glove, Large: 0.56 mg/glove, X-Large: 1.60 mg/glove (All ≤ 2 mg/glove) |
| Water Tight (ASTM D5151-19) | AQL 2.5 | Passes AQL 2.5 |
| Biocompatibility - Primary Skin Irritation (ISO 10993-10:2010) | Under the condition of study not an irritant | Under the condition of study, not an irritant |
| Biocompatibility - Dermal Sensitization (ISO 10993-10:2010) | Under the conditions of the study, not a sensitizer | Under the conditions of the study, not a sensitizer |
| Biocompatibility - In vitro Cytotoxicity (ISO 10993-5:2009) | Under the conditions of the study, non-cytotoxic | Under the conditions of the study, the device is cytotoxic. (Note: This is a discrepancy. The table in section F states "Similar" and describes it as "non-cytotoxic at 50%, 25%, 12.5% and 6.25% extracts." However, the table in section G, which details the bench test data, explicitly states "the device is cytotoxic." This is a significant finding that would typically require further explanation or clarification in a submission. Assuming the 'bench test data' result is the final documented finding for this specific test.) |
| Biocompatibility - Acute Systemic Toxicity Test (ISO 10993-11:2017) | Under the conditions of study, the device extracts do not pose a systemic toxicity concern | Under the conditions of study, the device extracts did not reveal any systemic toxicity |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes for each test in the provided tables. However, it indicates that the tests were conducted according to established ASTM and ISO standards, which typically specify sample size requirements.
- Provenance: This is a non-clinical device (examination gloves). The data provenance refers to laboratory bench testing. The location of the testing is not explicitly stated, but the applicant's address is in Thailand. Given the nature of bench testing, the "country of origin of the data" is the laboratory where the tests were performed, which is not specified beyond being conducted according to international standards. The data is prospective in the sense that these tests were performed specifically for this submission to demonstrate compliance.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. This device is a physical product (examination glove) and its performance is evaluated through standardized physical, chemical, and biocompatibility bench tests, not through expert interpretation of medical images or observations. Therefore, there is no "ground truth" established by medical experts in the traditional sense for an AI/medical imaging device.
4. Adjudication Method
Not applicable for this type of device and testing. Adjudication methods like 2+1 or 3+1 are used for human-in-the-loop evaluations, typically with medical image interpretation, to resolve discrepancies among experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not an AI/medical imaging device that would involve human readers or AI assistance in interpretation. It's a non-clinical evaluation of a physical product's safety and performance characteristics.
6. Standalone Performance Study
Yes, a standalone performance study was done. The entire "BENCH TEST DATA" section (pages 7-8) and "BIOCOMPATIBILITY DATA" section (page 8) outline the algorithm/device-only performance against predefined acceptance criteria from international standards (ASTM and ISO). There is no "human-in-the-loop" component described for these tests.
7. Type of Ground Truth Used
The "ground truth" for this device's performance relies on established international standards and specifications:
- ASTM D6319-19 (Standard Specification for Nitrile Examination Gloves for Medical Application)
- ASTM D5151-19 (Standard Test Method for Detection of Holes in Medical Gloves)
- ASTM D6124-06 (Reapproved 2017) (Standard Test Method for Residual Powder on Medical Gloves)
- ISO 10993-10:2010(E) (Biological Evaluation of Medical Devices - Part 10, Tests for Irritation and Skin Sensitization)
- ISO 10993-5:2009(E) (Biological Evaluation of Medical Devices - Part 5, Tests for In Vitro Cytotoxicity)
- ISO 10993-11:2017(E) (Biological Evaluation of Medical Devices - Part 11, Tests for Systemic Toxicity)
The device's physical and biological properties are measured and compared directly against the quantitative thresholds and qualitative outcomes specified in these standards.
8. Sample Size for the Training Set
Not applicable. This is not an AI device that requires a training set. The "device" here refers to the physical product (gloves).
9. How the Ground Truth for the Training Set was Established
Not applicable, as no training set is involved.
§ 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.