(83 days)
A powder-free 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.
The Powder Free Nitrile Examination Gloves are non sterile, single use, and disposable. These gloves are available in Blue, Green, and Black colors. This device is to protect the examiner and prevent contamination between patient and the examiner when properly worn. The sizes of the gloves are Small, Medium, Large and X-Large. Non Sterile Nitrile Powder Free Examination Gloves meet all current specifications listed under ASTM Specifications D6319.
The provided text describes the acceptance criteria and performance of "AAMedix Glove Sdn Bhd NON STERILE NITRILE POWDER FREE EXAMINATION GLOVES – BLUE, GREEN AND BLACK". This is a medical device, specifically examination gloves, and the information is presented in the context of an FDA 510(k) premarket notification.
Here's a breakdown of the requested information based on the provided document:
Acceptance Criteria and Device Performance
AAMedix Glove Sdn Bhd's Non Sterile Nitrile Powder Free Examination Gloves were tested against ASTM D6319 criteria. The device is compared to a predicate device (K143289) and its performance data are presented.
| Acceptance Criteria (ASTM D6319 Requirement) | Subject Device (K220121) Performance: BLUE/GREEN/BLACK Gloves | Predicate Device (K143289) Performance (where specified) |
|---|---|---|
| DIMENSIONS | ||
| Overall Length | ||
| - Small: 220 mm minimum | Pass (237-253 mm) | Not specified for Small |
| - Medium: 230 mm minimum | Pass (240-251 mm) | 240-250 mm |
| - Large: 230 mm minimum | Pass (240-255 mm) | Not specified for Large |
| - X-large: 230 mm minimum | Pass (240-277 mm) | Not specified for X-Large |
| Width | ||
| - Small: 80 +/-10 mm | Pass (85-88 mm) | Not specified for Small |
| - Medium: 95 +/-10 mm | Pass (95-98 mm) | 95-99 mm |
| - Large: 110 +/-10 mm | Pass (105-109 mm) | Not specified for Large |
| - X-large: 120 +/-10 mm | Pass (113-116 mm) | Not specified for X-Large |
| Palm Thickness | ||
| - Minimum: 0.05 mm | Pass (0.05-0.14 mm) | 0.05-0.06 mm |
| Finger Thickness | ||
| - Minimum: 0.05 mm | Pass (0.09-0.18 mm) | 0.09-0.10 mm |
| PHYSICAL PROPERTIES | ||
| Tensile Strength (Before Aging) | ||
| - Minimum: 14 MPa | Pass (21.2-46.5 MPa) | 28.46-33.44 MPa |
| Tensile Strength (After Aging) | ||
| - Minimum: 14 MPa | Pass (20.7-45.8 MPa) | 29.76-34.18 MPa |
| Ultimate Elongation (Before Aging) | ||
| - Minimum: 500% | Pass (460-600%) | 520-580% |
| Ultimate Elongation (After Aging) | ||
| - Minimum: 400% | Pass (440-580%) | 440-520% |
| FREEDOM FROM HOLES (Pinhole Inspection) | ||
| - AQL=2.5; Accept on 7 or 10 (n=200) | Pass (Found=0-6) | Holes found: 0 (Accept 1, Reject 7) |
| POWDER FREE/Residual Powder | ||
| - Does not exceed 2 mg per glove | Pass (Average: 0.04-1.02 mg per glove) | 0.20 mg/glove |
Study Details:
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Sample sizes used for the test set and the data provenance:
- Test Set Size: For the Freedom from Holes (Pinhole Inspection), the sample size was
n=200per glove size and color (Blue, Green, Black). For other physical properties and dimensions, the specific sample sizes used in the testing are not explicitly stated in the provided summary, beyond the fact that ranges of results are given ("e.g., 25.2-31.9 MPa"). - Data Provenance: The document is a 510(k) summary from AAMedix Glove Sdn Bhd, located in Malaysia. The testing would have been conducted by or for AAMedix Glove Sdn Bhd, likely in Malaysia or a testing facility compliant with international standards. The study is retrospective in the sense that the data are presented as results of completed tests to demonstrate equivalence to a predicate device.
- Test Set Size: For the Freedom from Holes (Pinhole Inspection), the sample size was
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document does not mention the use of experts to establish a "ground truth" in the traditional sense of clinical or diagnostic studies. The "ground truth" here is the adherence to established industry performance standards and test methods (specifically ASTM D6319 and D5151 for physical properties and freedom from holes). These standards define objective measurements that do not typically require expert interpretation for their results. -
Adjudication method for the test set:
Not applicable. The tests performed are objective physical and chemical tests based on ASTM standards. Adjudication methods like 2+1 or 3+1 are typically used in clinical imaging studies where there is subjective interpretation involved. -
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 not a study involving human readers or AI in a diagnostic or interpretive context. It's an evaluation of the physical and material properties of examination gloves. -
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is not an algorithm or software device. -
The type of ground truth used:
The "ground truth" for this device is the objective performance specifications defined by established industry standards, specifically ASTM D6319 and ASTM D5151. These standards specify acceptable ranges for physical properties (dimensions, tensile strength, elongation) and freedom from holes, as well as powder content. -
The sample size for the training set:
Not applicable. This device does not use a "training set" as it is not an AI/ML algorithm or a diagnostic device that requires learning from data. -
How the ground truth for the training set was established:
Not applicable, as there is no training set for this type of 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.