(25 days)
The Powder-Free Nitrile Examination Gloves, Non-Sterile (Blue) is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
The Powder-Free Nitrile Examination Gloves, Non-Sterile (Blue) 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 and single use only. The Powder-Free Nitrile Examination Gloves, Non-Sterile (Blue) is made of Nitrile, a synthetic rubber copolymer of acrylonitrile and butadiene. The device does not incorporate powder for purpose other than manufacturing. The final finished glove includes only residual powder from manufacturing. The Powder-Free Nitrile Examination Gloves, Non-Sterile is finishing through polymer coating process. The device is provided non-sterile.
This document is a 510(k) Premarket Notification for a medical device: "Powder-Free Nitrile Examination Glove, Non-Sterile". It demonstrates the device's substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study proving the device meets them, based on the provided text:
Important Note: This document is about a Class I medical device (examination gloves). For such devices, clinical studies (MRMC, algorithm-only performance, etc.) are generally not required, and the "ground truth" often refers to well-established physical and chemical standards rather than diagnostic outcomes. This is explicitly stated in Section 5.0: "Clinical testing is not needed for this device and review."
Therefore, many of the typical questions for AI/diagnostic devices regarding MRMC, standalone performance, and complex ground truth establishment are not applicable here. The focus is on demonstrating that the new glove meets existing performance standards and is biocompatible.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally defined by the ASTM (American Society for Testing and Materials) standards referenced, and the device performance is reported against these.
| Characteristic | Standard/Test Method | Purpose of Testing | Acceptance Criteria (Predicate/Guidance) | Reported Device Performance (CURRENT) | Status |
|---|---|---|---|---|---|
| Physical Properties | To evaluate the tensile (tension) properties of glove. | ||||
| Tensile Strength (Before Aging) | ASTM D412 (Standard Test Method for Vulcanized Rubber and Thermoplastic Elastomers-Tension) | Min 14.0 MPa (New Device) / 28 MPa min (Predicate) | 14.0 MPa | Pass | |
| Ultimate Elongation (Before Aging) | ASTM D412 | Min 500% (New Device) / 500% min (Predicate) | Min 500% | Pass | |
| Tensile Strength (After Aging) | ASTM D412 | Min 14.0 MPa (New Device) / 30 MPa min (Predicate) | 14.0 MPa | Pass | |
| Ultimate Elongation (After Aging) | ASTM D412 | Min 400% (New Device) / 480% min (Predicate) | Min 400% | Pass | |
| Dimensions | ASTM D3767 (Standard Practice for Rubber—Measurement of Dimensions) | To measure the length, width and thickness of glove. | |||
| Length | Min 230 mm | Min 230 mm | Pass | ||
| Width | Min 95 ± 10 mm | Min 95 ± 10 mm | Pass | ||
| Thickness (Finger) | 0.05 mm (New Device) / 0.10 mm (Predicate) | 0.05 mm | Pass | ||
| Thickness (Palm) | 0.05 mm (New Device) / 0.06 mm (Predicate) | 0.05 mm | Pass | ||
| Thickness (Cuff) | NA / 0.04 mm (Predicate) | NA | Pass | ||
| Powder Free | ASTM D6124 (Standard Test Method for Residual Powder on Medical Gloves) | To determine the amount of residual powder and non-powder solids found on gloves. | Less than 2 mg per glove | 1.2 mg/glove (Sample size: 5 pcs) | Pass |
| Biocompatibility | |||||
| Skin Sensitization | Dermal Sensitization - ISO 10993-10: 2010 (E) | To determine whether the subject device is a sensitizer. | Magnusson and Kligman grades of less than 1 | Non-Sensitizer to Guinea Pigs (0% sensitization rate) | Pass |
| Skin Irritation | Primary Skin Irritation - ISO 10993-10:2010 (E) | To determine whether the subject device is an irritant. | Primary or Cumulative Irritation Index (PII) of 0.4 or less | Non-irritant in New Zealand White Rabbits | Pass |
| Cytotoxicity | Cytotoxicity - MEM Elution, ISO 10993-5: 2009 (E) | To determine whether the subject device is cytotoxic. | Reactivity grade should not be greater than grade 2 or should show "mild reactivity". | Non-Cytotoxic on Hela Cells | Pass |
| Acute Systemic Toxicity | Acute Systemic Toxicity, ISO 10993-11:2017 (E) | To determine whether the subject device causes a systemic response. | 1. No animals showed significantly greater biological reactivity than solvent control. 2. No body weight loss > 10%. 3. No mortality or abnormal behavior. | Does not induce any systemic toxicity in Swiss albino mice | Pass |
| Watertight | ASTM D5151:2019 | (Implied: To ensure barrier integrity) | Inspection Level 1, AQL 1.5 | Inspection Level 1, AQL 1.5 | Same (Pass) |
2. Sample Size Used for the Test Set and Data Provenance
- Residual Powder Test Set Sample Size: 5 pieces (stated for the ASTM D6124 test).
- Other tests: Specific sample sizes for each physical properties and biocompatibility test are not explicitly detailed (e.g., how many gloves for tensile strength, or how many animals for biocompatibility tests), but the mention of standards like ASTM and ISO implies that standard sample sizes for those tests were used.
- Data Provenance: The tests are non-clinical bench performance tests. The specific geographic origin of the lab conducting the tests is not stated, but the company is "GoodGloves Industries Sdn Bhd" located in Malaysia. The tests are retrospective, conducted to demonstrate equivalence for the 510(k) submission.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- This is not applicable in the context of this device and study. "Ground truth" for examination gloves is established by objective, quantifiable physical and chemical tests defined by international standards (ASTM, ISO). There are no human experts subjectively interpreting outcomes for a "ground truth" label, as would be the case for diagnostic imaging.
4. Adjudication Method for the Test Set
- Not applicable. As noted above, the "ground truth" is based on objective measurements and established standards, not subjective assessments requiring adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
- No. Clinical studies, including MRMC studies, are explicitly stated as "not needed for this device and review" (Section 5.0).
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No. This device is not an algorithm or AI system. It is a physical medical device (glove).
7. The Type of Ground Truth Used
- The "ground truth" for this device is based on established international performance standards (ASTM, ISO) for physical properties (tensile strength, elongation, dimensions, watertightness, residual powder) and biocompatibility testing (skin sensitization, skin irritation, cytotoxicity, acute systemic toxicity) on animal models or cell cultures, as defined by relevant ISO standards.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set was Established
- Not applicable. 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.