(247 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.
Nitrile Powder Free Patient Examination Glove, Black 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 document is a 510(k) Premarket Notification from the FDA for a medical device: "Black Nitrile Powder Free Patient Examination Glove, Non Sterile". This document focuses on demonstrating substantial equivalence to a predicate device rather than undergoing a clinical trial for novel device performance.
Therefore, the requested information regarding acceptance criteria, study details, and ground truth establishment for a diagnostic algorithm (which is typical for AI/ML device submissions) is not applicable to this specific registration. This document describes the physical and chemical properties of a medical glove.
However, I can extract the acceptance criteria and reported device performance from the non-clinical testing performed to show equivalence with existing standards for examination gloves.
1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical Testing):
| Characteristic | Standard | Acceptance Criteria | Reported Device Performance (Current Black Nitrile Glove) | Status |
|---|---|---|---|---|
| Physical Properties (ASTM D412) | Before Aging | After Aging | ||
| Tensile Strength | ASTM D412 | Min 14.0 MPa | 32.35 Mpa | 36.10 Mpa |
| Ultimate Elongation | ASTM D412 | Min 500% | 568% | 551% |
| Dimension (ASTM D3767) | ||||
| Length | ASTM D3767 | Min 240 mm | 249 mm | N/A |
| Width | ASTM D3767 | 95 ± 10 mm | 98.0 mm | N/A |
| Thickness - Finger | ASTM D3767 | Min 0.05 mm | 0.10 mm | N/A |
| Thickness - Palm | ASTM D3767 | Min 0.05 mm | 0.07 mm | N/A |
| Watertight (ASTM D5151) | ||||
| AQL for Holes | ASTM D5151 | AQL: 1.5, Acceptance No. 10 (for specified sample size) | 0 pieces found with leaks (within acceptance criteria) | Pass |
| Residual Powder (ASTM D6124) | ||||
| Powder Amount | ASTM D6124 | Less than 2 mg per glove | 0.24 mg/glove | N/A |
| Biocompatibility | ||||
| Primary Skin Irritation | ISO 10993-10:2010 (E) & CPSCC Title 16, Ch. II, Part 1500 | Passes (no irritant response) | Negligible | N/A |
| Dermal Sensitization | ISO 10993-10:2010 (E) & CPSCC Title 16, Ch. II, Part 1500.3 (c)(4) | Passes (no sensitization effect) | No skin sensitization effect | N/A |
| Cytotoxicity - MEM Elution | ISO 10993-5:2009 (E) | Passes | Cytotoxic effect observed, but Acute Systemic Toxicity tested | N/A |
| Acute Systemic Toxicity | ISO 10993-11:2017 (E) | Not applicable (for predicate) | No systemic toxicity induced | N/A |
Further Requested Information (Not Applicable or Not Provided for this Device Type):
The following points are specifically relevant for AI/ML-powered diagnostic or decision support devices, which is not what this FDA submission is for. This document is for a physical medical glove. Therefore, the requested information below is not present in the provided text.
- Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable for a physical medical glove. The non-clinical tests involved sampling of gloves for physical and chemical property testing.
- 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): Not applicable. Ground truth for physical properties is established through standardized laboratory testing protocols, not expert consensus on diagnostic images.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the glove, the "ground truth" is defined by the technical specifications and testing methods in the ASTM and ISO standards (e.g., a hole is a hole if water leaks, tensile strength is measured by a specific test).
- The sample size for the training set: Not applicable. There is no AI model or algorithm being trained.
- How the ground truth for the training set was established: Not applicable.
Conclusion from document:
The provided document describes the non-clinical testing of a "Black Nitrile Powder Free Patient Examination Glove, Non Sterile" to demonstrate its substantial equivalence to a predicate device (K190942). The tests show that the glove meets or exceeds the requirements of relevant ASTM and ISO standards for physical properties, dimensions, watertight integrity, residual powder, and biocompatibility, thus clearing it for market. No clinical studies or AI/ML algorithm evaluations were part of this 510(k) submission.
§ 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.