(85 days)
Latex Examination Powder Free Gloves are disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Latex Examination Powder Free Gloves are manufactured to meet all the current specifications listed under the ASTM Specification D3578-2019, Standard Specification for Rubber Examination Gloves. They are made from Natural Rubber Latex. These gloves are natural in color (No color is added) and are powder free and Non-Sterile.
The provided document describes the FDA 510(k) premarket notification for "Latex Examination Powder Free Gloves." This is a Class I medical device, which typically does not require a complex AI/algorithm-based study with human readers, ground truth establishment by experts, or MRMC studies. The approval is based on demonstrating substantial equivalence to a predicate device through non-clinical performance data against established industry standards.
Therefore, many of the requested elements for describing AI acceptance criteria and study methodology (like sample sizes for test/training sets, expert ground truth, adjudication, MRMC studies, standalone algorithm performance, etc.) are not applicable to this type of device and submission.
The document explicitly states "H. SUMMARY OF CLINICAL TESTING: Not applicable." This reinforces that the submission did not rely on clinical performance data involving human readers or sophisticated AI algorithms.
However, I can extract the acceptance criteria and performance data as presented for these gloves.
Acceptance Criteria and Reported Device Performance
The acceptance criteria for the "Latex Examination Powder Free Gloves" are based on established ASTM (American Society for Testing and Materials) standards for rubber examination gloves. The table below summarizes these criteria and the reported performance of the device (K222348) compared to the predicate device (K192329).
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics / Test Method | Standard / Purpose | Acceptance Criteria (K192329 Predicate) | Reported Device Performance (K222348 - Current Device) | Comparison |
|---|---|---|---|---|
| Dimensions - Length (ASTM D3578-2019) | To determine the length of the gloves | > 230 mm (all sizes) | > 230 mm (Actual values: X-Small 305 mm, Small 306 mm, Medium 307 mm, Large 308 mm, X-Large 310 mm) | Similar |
| Dimensions - Width (ASTM D3578-2019) | To determine the width of the gloves | Min 95+/-10 mm (for medium size) | X-Small 76 mm, Small 85 mm, Medium 96 mm, Large 106 mm, X-Large 116 mm | Similar |
| Physical Properties - Tensile Strength (ASTM D3578-2019) | To Determine the physical properties | Before Ageing: > 18 Mpa (all sizes) | ||
| After Ageing: > 14 Mpa (all sizes) | Before Ageing: X-Small 22.07 Mpa, Small 22.15 Mpa, Medium 22.22 Mpa, Large 22.30 Mpa, X-Large 22.32 Mpa | |||
| After Ageing: X-Small 18.49 Mpa, Small 18.56 Mpa, Medium 18.67 Mpa, Large 18.74 Mpa, X-Large 18.76 Mpa | Similar | |||
| Physical Properties - Ultimate Elongation (ASTM D3578-2019) | To Determine the physical properties | Before Ageing: > 650% (all sizes) | ||
| After Ageing: > 500% (all sizes) | Before Ageing: X-Small 858%, Small 869%, Medium 874%, Large 880%, X-Large 882% | |||
| After Ageing: X-Small 841%, Small 848%, Medium 854%, Large 860%, X-Large 862% | Similar | |||
| Thickness (ASTM D3578-2019) | To determine the thickness of the gloves | Palm > 0.08 mm, Finger > 0.08 mm (all sizes) | Palm: 0.16mm (all sizes) | |
| Finger: 0.22mm (all sizes) | Similar | |||
| Powder Free Residue (ASTM D6214) | To determine the residual powder in the gloves | ≤ 2 mg/glove | X-Small 0.21 mg/glove, Small 0.21 mg/glove, Medium 0.22 mg/glove, Large 0.22 mg/glove, X-Large 0.22 mg/glove | Similar |
| Protein Content (ASTM D5712) | To determine the extractable protein in the gloves | Max 200 µg/dm² | 43.19 µg/dm² (reported as 43.65 µg/dm² for all sizes in detailed results) | Similar |
| Biocompatibility - Primary Skin Irritation (ISO 10993-10:2010) | Not specified in detail, but expected to ensure safe contact with skin. | Under the condition of study, not an irritant | Under the condition of study, not an irritant | Same |
| Biocompatibility - Dermal Sensitization (ISO 10993-10:2010) | Not specified in detail, but expected to ensure safe contact with skin. | Under the conditions of the study, not a sensitizer | Under the conditions of the study, not a sensitizer | Same |
| Biocompatibility - In vitro cytotoxicity (ISO 10993-5:2009) | Not specified in detail, but expected to ensure no toxic effects on cells. | Under the conditions of the study, cytotoxic (This might be a typo and should be "not cytotoxic", or it implies a specific acceptable level of cytotoxicity.) | Under the conditions of the study, cytotoxic (As above, likely implies within acceptable limits for the device type, or a typo). | Same |
| Biocompatibility - Acute Systemic Toxicity Test (ISO 10993-11:2017) | Not specified in detail, but expected to ensure no systemic toxic effects. | Device extracts do not pose a systemic toxicity concern | Device extracts do not pose a systemic toxicity concern | Same |
| Water Tightness (ASTM D5151-2019) | To determine the holes in the gloves | AQL 2.5 | Passes AQL 1.5 (AQL 1.5 is a tighter requirement than AQL 2.5, indicating better performance) | Same |
| Material-mediated Pyrogenicity (ISO 10993-11:2017 / USP 41) | To ensure the material does not cause fever. | Under the conditions of the study, non-pyrogenic | No data available (for the current device in this specific row, but typically expected for such devices. May be covered by general biocompatibility; the predicate was non-pyrogenic). | ---- |
| Intended use/Indication for use | JR MEDIC Blue Latex Examination Powder Free Gloves are disposable devices intended for medical purpose that are worn on the examiner's hand to prevent contamination between patient and examiner. | JR MEDIC Blue Latex Examination Powder Free Gloves are disposable devices intended for medical purpose that are worn on the examiner's hand to prevent contamination between patient and examiner. | Latex Examination Powder Free Gloves are disposable devices intended for medical purpose that are worn on the examiner's hand to prevent contamination between patient and examiner. | Similar |
| Material | - | Natural Latex | Natural Latex | Same |
| Color | - | Blue | Natural (No color is added) | Different |
| Texture | - | Finger Texture | Finger texture | Same |
| Size | ASTM D3578-2019 | Small, Medium, Large & X Large | X Small, Small, Medium, Large, X-Large (Added X-Small size) | Similar |
| Single Use | Medical Glove Guidance Manual - Labeling | Single Use | Single Use | Same |
| Sterile/non sterile | - | Non sterile | Non sterile | Same |
| Powder/Powder free | - | Powder free | Powder free | Same |
Study Details (Applicable to this Device Type)
Given this is a 510(k) for examination gloves, the "study" is a series of non-clinical, laboratory tests performed according to specific ASTM and ISO standards, rather than a clinical trial or an AI algorithm performance study.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes for each specific test (e.g., how many gloves were tested for length, width, or tensile strength). However, it implies that standard testing methodologies as defined by ASTM and ISO were followed. These standards usually specify the number of samples required for each test. The data provenance is from JR Engineering & Medical Technologies (M) SDN.BHD., Malaysia, indicating the tests were conducted by the manufacturer or a contracted lab in Malaysia. The data is non-clinical performance data, reported as part of a premarket notification.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. The "ground truth" for this device is physical and chemical adherence to specific measurable standards (e.g., a glove is X mm long, has Y tensile strength), not a diagnostic interpretation requiring expert medical opinion. The standards themselves, like ASTM D3578-2019, serve as the "ground truth" for performance.
4. Adjudication Method for the Test Set:
Not applicable. This is not a human-interpreted diagnostic task requiring adjudication. The tests are objective measurements against defined criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, this was not done. MRMC studies are typically for diagnostic imaging devices or algorithms where the performance of human readers (with and without AI assistance) on clinical cases is evaluated. This device is an examination glove.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No, this is not an AI algorithm. Its performance is measured through physical and chemical properties.
7. The Type of Ground Truth Used:
The ground truth used is objective engineering and material science standards (e.g., ASTM D3578-2019, ASTM D5151-2019, ASTM D6124-06, ASTM D5712-95, ISO 10993 series). These are internationally recognized standards for manufacturing and safety.
8. The Sample Size for the Training Set:
Not applicable. This is not an AI device trained on a dataset. The "training" for such a device would be the manufacturing process development and quality control to ensure consistency.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as it's not an AI training set. The "ground truth" for manufacturing would be the specifications and quality control procedures adherence to ensure gloves meet the physical and chemical standards.
§ 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.