(99 days)
A Powder free Nitrile Examination Gloves is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
ATM® Glove Powder free Nitrile Examination gloves is a Class I device bearing the product code LZA (21CFR 880.6250). They meet all the current specifications listed under the ASTM D6319 -19 Standard Specification for Nitrile Examination Gloves for Medical Application. They are made from acrylonitrilebutadiene copolymer dispersion. These gloves are blue in color having Finger Texture, Ambidextrous and are powder free. The product is non-sterile.
Here's an analysis of the provided text regarding the acceptance criteria and study for the ATM® Glove Powder free Nitrile Examination gloves, formatted to address your specific questions.
Device Under Review:
ATM® Glove Powder free Nitrile Examination gloves
Study Type: This document describes a 510(k) submission, demonstrating substantial equivalence to a predicate device for medical gloves. As such, the "study" is a series of non-clinical performance and biocompatibility tests rather than a clinical trial involving human patients or complex AI algorithms.
1. Table of Acceptance Criteria and Reported Device Performance
Context: The acceptance criteria for these examination gloves are based on established ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization) standards. The reported performance demonstrates compliance with these criteria.
| Test Category | Specific Test / Parameter | Acceptance Criteria | Reported Device Performance (ATM® Glove) | Pass/Fail |
|---|---|---|---|---|
| Dimensions (ASTM D6319-19) | Length (all sizes) | 230mm min | S: 245mm, M: 247mm, L: 247mm, XL: 244mm | Pass |
| Width (S) | 80mm ±10 | 85mm | Pass | |
| Width (M) | 95mm ±10 | 94mm | Pass | |
| Width (L) | 110mm ±10 | 106mm | Pass | |
| Width (XL) | 120mm ±10 | 112mm | Pass | |
| Thickness - Palm (all sizes) | 0.05 mm min | S: 0.07 mm, M: 0.07 mm, L: 0.06 mm, XL: 0.07 mm | Pass | |
| Thickness - Finger (all sizes) | 0.05 mm min | S: 0.11 mm, M: 0.12 mm, L: 0.11 mm, XL: 0.11 mm | Pass | |
| Physical Properties (ASTM D6319-19) | Tensile Strength - Before Aging (all sizes) | 14 Mpa Min (for all sizes) | S: 19.9 Mpa, M: 25.6 Mpa, L: 21.0 Mpa, XL: 23.1 Mpa | Pass |
| Tensile Strength - After Aging (all sizes) | 14 Mpa Min (for all sizes) | S: 18.9 Mpa, M: 27.7 Mpa, L: 20.5 Mpa, XL: 22.4 Mpa | Pass | |
| Ultimate Elongation - Before Aging (all sizes) | 500% Min (for all sizes) | S: 518%, M: 517%, L: 558% (XL data not explicitly provided but implied pass) | Pass | |
| Ultimate Elongation - After Aging (all sizes) | 400% Min (for all sizes) | S: 472%, M: 452%, L: 547% (XL data not explicitly provided but implied pass) | Pass | |
| Barrier Property | Detection of Holes (AQL 2.5) (ASTM D6319-19 / ASTM D5151-19) | Passes AQL 2.5 (for all sizes) | AQL 2.5 (for S, M, L, XL) | Pass |
| Powder Residue (ASTM D6124-06) | Residual Powder Content | ≤2 Mg/Glove Max (for all sizes) | S: 0.36 mg/glove, M: 0.16 mg/glove, L: 0.10 mg/glove, XL: 0.40 mg/glove | Pass |
| Biocompatibility (ISO 10993 Series) | In Vitro Cytotoxicity (ISO 10993-5:2009) | Non-cytotoxic to L-929 cells | Non-cytotoxic to L-929 cells | Pass |
| Skin Sensitization (ISO 10993-10:2010) | Not a sensitizer | Not a sensitizer | Pass | |
| Skin Irritation (ISO 10993-10:2010) | Not an irritant | Not an irritant | Pass | |
| Acute Systemic Toxicity (ISO 10993-11:2017) | Device extracts do not pose a systemic toxicity concern | Device extracts do not pose a systemic toxicity concern | Pass | |
| Material-Mediated Pyrogenicity (ISO 10993-11:2017, USP 43 ) | Device did not demonstrate a material mediated pyrogenicity response | Device did not demonstrate a material mediated pyrogenicity response | Pass |
2. Sample Sizes Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not explicitly state the exact sample sizes (e.g., number of gloves tested for each parameter) for the performance and biocompatibility tests. However, it indicates that the tests were performed "according to the requirements of Guidance for Industry and FDA Staff - Medical Glove Guidance Manual" and specific ASTM/ISO standards, which typically prescribe minimum sample sizes for statistical validity.
- Data Provenance:
- Country of Origin of the Data: The testing was conducted for PHU DUC HUY PRODUCTION TRADING SERVICES CORPORATION, located in Vietnam. The test data would originate from the facility where these tests were performed, presumably in Vietnam or a certified lab commissioned by the manufacturer.
- Retrospective or Prospective: The testing described is clearly prospective as it's part of a premarket notification (510(k)) to demonstrate the new device's conformity to standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable: For medical gloves, "ground truth" is established by adherence to established, international consensus standards (ASTM, ISO). These standards define the test methodologies and acceptance criteria, rather than relying on human expert consensus for individual test outcomes (e.g., a radiologist for image interpretation). The "experts" involved are those who designed and validate these standards, and those performing the laboratory tests according to certified procedures.
4. Adjudication Method for the Test Set
- Not Applicable: No human "adjudication" (like 2+1 or 3+1 consensus) is performed for these physical and biocompatibility tests. The outcome of each test is a measurable result (e.g., tensile strength in Mpa, AQL score, presence/absence of cytotoxicity) that is then compared against predefined numerical or categorical acceptance criteria from recognized standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No: An MRMC comparative effectiveness study is designed to evaluate the performance of diagnostic devices, especially those involving human interpretation, sometimes aided by AI. This is not relevant for the evaluation of medical gloves, which are physical barrier devices.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not Applicable: This device is a physical medical glove and does not involve any algorithms, AI, or software, hence no standalone (algorithm-only) performance testing was conducted.
7. The Type of Ground Truth Used
- Standardized Test Methods and Predefined Acceptance Criteria: The "ground truth" for the device's performance is the adherence to the requirements outlined in internationally recognized standards such as ASTM D6319-19 (Standard Specification for Nitrile Examination Gloves for Medical Application), ASTM D5151-19 (Standard Test Method for Detection of Holes in Medical Gloves), ASTM D6124-06 (Reapproved 2017) (Standard Test Method for Residual Powder on Medical Gloves), and ISO 10993 series (Biological Evaluation of Medical Devices). These standards set the benchmarks for physical properties, barrier integrity, and biocompatibility.
8. The Sample Size for the Training Set
- Not Applicable: Medical gloves do not involve "training sets" in the context of machine learning or AI. The product is manufactured and then tested against established quality controls.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable: As there is no training set for an AI/ML model for this device, there is no ground truth established in that context.
§ 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.