(262 days)
The Sterile Latex Patient Examination gloves, Powder Free, is a disposable device intended for medical purposes that is worn on the examiners' hand or finger to prevent contamination between patient and examiner.
The subject device is a patient examination glove made of latex compound. It is sterile, Powder Free. The device is ambidextrous and can be worn on either the left or right hand. The device meets ASTM D3578-05: Standard specification for Rubber Examination Gloves. The subject device is substantially equivalent to legally marketed Latex Examination Powder Free gloves identified as Product code LYY. The device is for over-the counter single use.
The provided document is a 510(k) premarket notification for a medical device: SANCARE STERILE LATEX EXAMINATION GLOVES.
It describes the device's characteristics and compares its performance against a legally marketed predicate device (K052728, Powder free Latex Sterile Patient Examination Gloves from M/S. KANAM LATEX INDUSTRIES PVT. LTD.) to establish substantial equivalence.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the SANCARE STERILE LATEX EXAMINATION GLOVES are primarily based on established ASTM standards and FDA water leak tests, as compared to the performance of the predicate device. The document explicitly states that the device "Meets" all specified standards.
| Characteristic | Test / Standard | Acceptance Criteria (from Standard) | Reported Device Performance (SANCARE STERILE LATEX EXAM GLOVES) | Result |
|---|---|---|---|---|
| Freedom from Pinholes | FDA 1000 ml water leak test, ASTM D5151-06 (Re-approved 2011) | ISO 2859-1 / G1 / AQL 2.5 (PASS/FAIL) | PASS | PASS |
| Dimensions | ||||
| Length | ASTM D3578-05 | ISO 2859-1 / S2 / AQL 4.0 (min 230 mm) | > 230 mm | PASS |
| Width | ASTM D3578-05 | ISO 2859-1 / S2 / AQL 4.0 (70±10 mm to 120±10 mm (sizes XS to XL)) | 70±10 mm to 120±10 mm (sizes XS to XL) | PASS |
| Thickness | ASTM D3578-05 | ISO 2859-1 / S2 / AQL 4.0 (min 0.08 mm (Cuff, palm & finger)) | > 0.08 mm (Cuff, palm& finger) | PASS |
| Physical Properties | ||||
| Before aging (Tensile Strength) | ASTM D3578-05 / ASTM D412-06 | ISO 2859-1 / S2 / AQL 4.0 (> 18 Mpa) | > 18 Mpa | PASS |
| Before aging (Ultimate Elongation) | ASTM D3578-05 / ASTM D412-06 | ISO 2859-1 / S2 / AQL 4.0 (> 650%) | >650% | PASS |
| Before aging (Stress at 500% elongation) | ASTM D3578-05 / ASTM D412-06 | ISO 2859-1 / S2 / AQL 4.0 (5.5 Mpa max) | 5.5 Mpa max | PASS |
| After Accelerated aging (Tensile Strength) | ASTM D3578-05 / ASTM D573-04 | ISO 2859-1 / S2 / AQL 4.0 (> 14 Mpa) | > 14 Mpa | PASS |
| After Accelerated aging (Ultimate Elongation) | ASTM D3578-05 / ASTM D573-04 | ISO 2859-1 / S2 / AQL 4.0 (> 500%) | > 500% | PASS |
| Powder-free residue | ASTM D3578-05 / ASTM D6124-06 | N=5 (Less than 2 mg per glove) | Less than 2 mg per glove | PASS |
| Residual Protein | ASTM D3578-05 / ASTM D5712-15 | N=3 (Less than 50µg/dm²) | Less than 50µg/dm² | PASS |
| Biocompatibility | ||||
| Primary skin irritation | ISO 10993-10 | Under the conditions of the study, the device is not an irritant | Non-irritant | PASS |
| Skin Sensitization | ISO 10993-10 | Under the conditions of the study, the device is not a sensitizer | Non-sensitizer | PASS |
| Sterility | ISO 11737-2 | Sterile | Sterile | PASS |
| Expiration dating/Shelf life | ASTM D7160-05 | (Not explicitly stated as Pass/Fail but confirmed) | Three years | Meets |
| Sterilization | ISO 11135-2014(E) | (Not explicitly stated as Pass/Fail but confirmed) | Meets (Ethylene Oxide) | Meets |
2. Sample Sizes Used for Test Set and Data Provenance
Specific sample sizes for each test are provided within the table under "Sampling plan / Inspection level / AQL":
- Freedom from Pinholes: ISO 2859-1 / G1 / AQL 2.5
- Dimensions (Length, Width, Thickness): ISO 2859-1 / S2 / AQL 4.0 for each
- Physical Properties (Before & After aging): ISO 2859-1 / S2 / AQL 4.0 for each
- Powder-free residue: N=5
- Residual Protein: N=3
The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. Given that it's a 510(k) submission for a finished medical device (gloves), the performance data would typically be generated by the manufacturer through in-house testing or contracted labs, following international standards (ASTM, ISO).
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable to this type of device and submission. This is a submission for examination gloves, which are evaluated based on physical, chemical, and biological performance characteristics against recognized standards, not clinical diagnostic accuracy requiring expert interpretation of images or patient data.
4. Adjudication Method for the Test Set
This information is not applicable. The device's performance is determined by objective laboratory tests against pre-defined thresholds from standards, not through adjudication of expert opinions.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (e.g., AI algorithms for medical imaging) that involve human readers' interpretation of outputs. For examination gloves, the evaluation criteria are entirely different, focusing on physical properties, safety, and sterility.
6. If a Standalone Study Was Done (Algorithm Only Without Human-in-the-loop Performance)
No, a standalone "algorithm only" study was not done. This concept is specific to AI or software as a medical device (SaMD). The SANCARE STERILE LATEX EXAMINATION GLOVES are a physical, Class I medical device. The performance data presented (e.g., tensile strength, freedom from holes) are inherent characteristics of the gloves themselves, independent of any algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's evaluation is based on established international performance standards (ASTM D3578-05, ASTM D5151-06, ASTM D412-06, ASTM D6124-06, ASTM D5712-15, ISO 10993-10, ASTM D7160-05, ISO 11135-2014(E), ISO 11737-2) and FDA-specific tests (FDA 1000ml water leak test). These standards define acceptable ranges or conditions for physical properties, biocompatibility, and sterility.
8. The Sample Size for the Training Set
This information is not applicable. There is no "training set" in the context of examination gloves. This term typically refers to data used to train machine learning models, which are not involved in the manufacturing or evaluation of this device.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no training set for this 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.