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510(k) Data Aggregation
(40 days)
A nitrile patient examination glove is a disposable device made of nitrile rubber intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner
Violet Nitrile Powder-Free Patient Examination Glove, Non-Sterile meets all requirements of ASTM D6319 standard and FDA 21 CFR 880.6250. The powder free nitrile examination glove is manufactured from nitrile rubber. Innersurface 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 or silicone on the glove surface. The glove is ambidextrous, i.e., can be worn on right or left hand.
The provided text describes the acceptance criteria and performance data for a medical device: "Violet Nitrile Powder Free Patient Examination Glove, Non Sterile" (K222721). This is a physical product, not an AI/ML powered medical device. Therefore, the questions related to AI/ML specific criteria, such as "multi-reader multi-case (MRMC) comparative effectiveness study," "standalone (algorithm only) performance," or "sample size for the training set," are not applicable.
Here's the relevant information based on the provided text, primarily derived from the "Summary of Non-Clinical Testing" (Section 7.0) and "Comparison of the Technological Characteristics of the Device" (Table 1):
1. A table of acceptance criteria and the reported device performance
| Test Method (Standard) | Purpose of Testing | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Physical Properties (ASTM D412) | To evaluate the tensile (tension) properties of glove. | ||
| - Tensile Strength (Before Aging) | Min 14.0 MPa | XS – 28.8 MPa; S – 29.2 MPa; M – 28.0 MPa; L – 27.2 MPa; XL – 26.8 MPa | |
| - Tensile Strength (After Aging) | Min 14.0 MPa | XS – 30.8 MPa; S – 32.2 MPa; M – 31.0 MPa; L – 31.6 MPa; XL – 30.6 MPa | |
| - Ultimate Elongation (Before Aging) | Min 500% | XS – 520%; S – 550%; M – 540%; L – 560%; XL – 540% | |
| - Ultimate Elongation (After Aging) | Min 400% | XS – 460%; S – 470%; M – 480%; L – 460%; XL – 450% | |
| Dimension (ASTM D3767) | To measure the length, width and thickness of glove | ||
| - Length | Min 240 mm (for sizes S, M, L, XL), 243 mm (for XS) | XS: 243 mm; S: 243 mm; M: 243 mm; L: 242 mm; XL: 248 mm | |
| - Width | 70 ± 10 mm (XS); 80 ± 10 mm (S); 95 ± 10 mm (M); 110 ± 10 mm (L); 120 ± 10 mm (XL) | XS: 75.0 mm; S: 85.0 mm; M: 95.0 mm; L: 106 mm; XL: 115 mm | |
| - Finger Thickness | Min 0.05 mm | XS: 0.10 mm; S: 0.10 mm; M: 0.10 mm; L: 0.10 mm; XL: 0.10 mm | |
| - Palm Thickness | Min 0.05 mm | XS: 0.06 mm; S: 0.06 mm; M: 0.06 mm; L: 0.06 mm; XL: 0.06 mm | |
| Watertight (ASTM D5151) | To detect holes that leak water | Sample size: 315 pcs, Inspection level: G1, AQL: 1.5, Acceptance No. 10 | For Size XS: 3 pieces with leaks; For Size S: 1 piece with leaks; For Size M: 2 pieces with leaks; For Size L: 2 pieces with leaks; For Size XL: 1 piece with leaks. All these results fall within the acceptance criteria. |
| Residual Powder (ASTM D6124) | To determine the amount of residual powder | Less than 2 mg per glove (< 2mg/glove) | XS: 0.33 mg/glove; S: 0.28 mg/glove; M: 0.26 mg/glove; L: 0.30 mg/glove; XL: 0.34 mg/glove (Note: Document has two entries for XL, selecting the lowest one for consistency) |
| Biocompatibility | |||
| - Primary Skin Irritation (ISO 10993-10) | Evaluate irritant response | "Under the conditions of this study, the device is non-irritant and non-sensitizer" (Predicate criteria) | "Under conditions of this study, the test material did not cause an irritant response. The Primary Irritant Response Category is deemed 'Negligible'." (Current device) |
| - Dermal Sensitization (ISO 10993-10) | Evaluate skin sensitization effects | "Under the conditions of this study, the test device is non-irritant and non-sensitizer." (Predicate criteria) | "Under conditions of this study, the test material did not produce a skin sensitization effect in the guinea pigs." (Current device) |
| - Acute Systemic Toxicity (ISO 10993-11) | Assess systemic toxicity | Not Tested (Predicate) | "Under conditions of this study, the test item did not induce any systemic toxicity in Swiss albino mice." (Current device) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Physical Properties (Tensile Strength, Ultimate Elongation): The sample sizes are specified by size (XS, S, M, L, XL) with individual results reported. However, the exact number of gloves tested for each size isn't explicitly stated in the summary, only the aggregate outcome for each size category.
- Dimension: Results are reported for each glove size (X-Small, Small, Medium, Large, X-Large), but the specific sample size for each dimension measurement per size is not explicitly stated in the summary.
- Watertight: The sample size was 315 pieces per size, for an AQL (Acceptable Quality Limit) test, based on a batch size of 150,001 to 500,000.
- Residual Powder: The sample size was 5 pieces per glove size.
- Biocompatibility (Skin Irritation, Dermal Sensitization, Acute Systemic Toxicity): The sample sizes for these biological tests are not specified in the provided tables, but "guinea pigs" and "Swiss albino mice" are mentioned as test subjects for sensitization and systemic toxicity, respectively.
The data provenance (country of origin, retrospective/prospective) is not explicitly stated in this summary. The submitter is "Safeskin Retailing (HK) Limited" (Hong Kong), but where the actual testing took place or the data was collected isn't detailed.
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 question is not applicable as the device is a physical glove, not an AI/ML device requiring expert ground truth for classification or diagnosis. The "ground truth" for these tests are objective measurements according to established ASTM and ISO standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is for a physical device and not an AI/ML diagnosis/detection system where adjudication of expert opinions would be necessary. The tests are objective measurements against defined standards.
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 for an AI/ML powered medical device. The submitted device is a physical examination glove.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is for an AI/ML powered medical device. The submitted device is a physical examination glove.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this physical device, the "ground truth" is established by adherence to recognized international standards and specifications for medical gloves, such as:
- ASTM D412: Standard Test Method for Vulcanized Rubber and Thermoplastic Elastomers—Tension.
- ASTM D3767: Standard Practice for Rubber—Measurement of Dimensions.
- ASTM D5151: Standard Test Method for Detection of Holes in Medical Gloves.
- ASTM D6124: Standard Test Method for Residual Powder on Medical Gloves.
- ASTM D6319: Standard Specification for Nitrile Examination Gloves for Medical Application.
- ISO 10993-10: Biological evaluation of medical devices – Tests for irritation and skin sensitization.
- ISO 10993-11: Biological evaluation of medical devices – Tests for systemic toxicity.
- ISO 2859: Sampling Procedures and Tables for Inspection by Attributes.
These standards define objective measurement methodologies and acceptable ranges for various physical and biocompatibility properties.
8. The sample size for the training set
Not applicable. This is a physical device, and AI/ML "training sets" are not part of its development or testing for this submission.
9. How the ground truth for the training set was established
Not applicable. This refers to AI/ML development.
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