(166 days)
Tegamen Nitrile Patient Examination gloves, is a disposable device intended for medical purposes that is worn on the examiners' hand or finger to prevent contamination between patient and examiner.
The subject device in this 510(k) Notification is Tegamen Nitrile Examination Gloves, Powder Free. The subject device is a patient examination glove made from nitrile compound, blue color, powder free and non-sterile (Per 21 CFR 880.6250, Class I). The device meets the specifications in ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.
This document describes the premarket notification for the "Tegamen Nitrile Examination Gloves" (K223102) and its substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study data:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method | Purpose | Acceptance Criteria (from D6319-19 and other ISO standards) | Reported Device Performance (Tegamen Nitrile Examination Gloves) |
|---|---|---|---|
| Physical Dimensions (ASMT D6319-19) | To determine the width, length, and thickness of the gloves | * Length: > 230 mm (240-400mm) | * Pass |
| * Width: 70±10 mm to 120±10 mm (sizes XS to XL) | * Length (mm) Mean Value: 239.45 | ||
| * Thickness: > 0.05 mm (palm & finger) | * Width (mm) Mean Value: 84.7 (small), 95.9 (medium), 105.8 (large), 115.5 (extra large) | ||
| * Thickness at finger (mm) Mean Value: 0.13 | |||
| * Thickness at Palm (mm) Mean Value: 0.065 | |||
| Physical Requirements (ASMT D6319-19) - Tensile Strength & Elongation | To determine the tensile strength and ultimate elongation before and after aging | * Before Acceleration Aging: | * Pass |
| * Tensile Strength: 14 Mpa min | * Tensile Strength (MPa) Mean Value before aging: 23.24 | ||
| * Ultimate Elongation: 500 % min | * Ultimate Elongation (Mean Value) before aging: 851.9 | ||
| * After Acceleration Aging: | * Tensile Strength (MPa) Mean Value after aging: 22.62 | ||
| * Tensile Strength: 14 Mpa min | * Ultimate Elongation (Mean Value) after aging: 808.7 | ||
| * Ultimate Elongation: 400 % min | |||
| Detection of Holes (ASTM D6319-19, ASTM D5151-11) | To determine the holes in the gloves | AQL (Acceptance Quality Limit) 2.5 | * Pass |
| * Total Defects: 01 (Holes found 1) | |||
| Residual Powder (ASMT D6319-19, ASTM D6124-11) | To determine the residual powder in the gloves | ≤ 2.0 mg/glove | * Pass |
| * Powder Content (mg/glove): 1.335 | |||
| Skin Irritation (ISO 10993-10) | To determine the potential of the material to produce skin irritation in rabbits | Under the condition of study not an irritant | * Under the condition of study not an irritant |
| Skin Sensitization (ISO 10993-10) | To determine the skin sensitization potential in guinea pigs | Under the conditions of the study not a sensitizer. | * Under the conditions of the study not a sensitizer. |
| In vitro Cytotoxicity (ISO 10993-5) | To evaluate the in vitro cytotoxic potential of the test item in L-929 mouse fibroblasts cells using elution method | Under the conditions of study cytotoxic | * Cytotoxic in undiluted extract, 1:2, 1:4, 1:8, and 1:16 dilutions. Non-cytotoxic to L-929 cells at 1:32 dilutions (This states the acceptance criteria as "cytotoxic" but then the result details the levels of cytotoxicity. This is a common phrasing where 'cytotoxic' isn't necessarily a 'fail' but rather describes the finding which then needs to be contextualized by the dilutions). |
| Acute Systemic Toxicity (ISO 10993-11:2017) | The test item was evaluated for acute systemic toxicity in Swiss Albino Mice | Under the conditions of the study no acute systemic toxicity | * Under the conditions of the study no acute systemic toxicity |
Summary of Device Performance: The Tegamen Nitrile Examination Gloves passed all physical and chemical performance tests specified by ASTM D6319-19 (including dimensions, tensile strength, ultimate elongation, freedom from holes, and residual powder). In biocompatibility testing, the gloves were found to be non-irritant, non-sensitizer, and showed no acute systemic toxicity. While the cytotoxicity test reported cytotoxicity at higher concentrations, it was non-cytotoxic at a 1:32 dilution, which is typical for some materials and needs to be evaluated in context of direct patient contact and exposure levels.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the exact sample sizes for each specific test (e.g., number of gloves tested for holes, number of mice for toxicity, etc.). However, it refers to standard test methods (ASTM D6319-19, ASTM D5151-11, ASTM D6124-11, ISO 10993 series), which inherently prescribe statistical sampling plans for each test. For example, ASTM D5151-11 (Detection of Holes in Medical Gloves) would specify a sample size based on the lot size and AQL.
- Data Provenance: The device manufacturer, Tegamen Safety products Ltd, is located in Ghiloth Alwar, Rajasthan, India. Therefore, the testing was presumably conducted in India or a facility contracted by the manufacturer. The data is retrospective, generated specifically for this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable (N/A) to this type of device submission. This is a medical glove, a Class I device, and the testing involves objective physical, chemical, and biological tests based on established standards (ASTM, ISO). There is no "ground truth" established by human experts in the way it would be for an AI diagnostic device (e.g., expert radiologists evaluating images). The ground truth is defined by the measurable parameters and pass/fail criteria of the specified ASTM and ISO standards.
4. Adjudication Method for the Test Set
This information is not applicable (N/A) for the same reasons as point 3. Adjudication methods like 2+1 or 3+1 are used in studies where human experts disagree on a subjective assessment, typically in image interpretation or clinical diagnosis. The tests performed for this device are objective measurements against defined criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance
This information is not applicable (N/A). This device is a nitrile examination glove, not an AI diagnostic tool. Therefore, MRMC studies and the concept of human reader improvement with AI assistance are irrelevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
This information is not applicable (N/A). This device is a physical medical glove, not an algorithm or AI system.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context is defined by the objective, measurable standards and specifications set forth in:
- ASTM D6319-19 (Standard Specification for Nitrile Examination Gloves for Medical Application)
- ASTM D5151-11 (Standard Test Method for Detection of Holes in Medical Gloves)
- ASTM D6124-11 (Standard Test Method for Residual Powder on Medical Gloves)
- ISO 10993-5 (Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity)
- ISO 10993-10 (Biological evaluation of medical devices – Part 10: Tests for skin irritation and skin sensitization)
- ISO 10993-11:2017 (Biological evaluation of medical devices – Part 11: Tests for acute systemic toxicity)
The device's performance metrics are directly compared against the values and thresholds specified in these international standards.
8. The Sample Size for the Training Set
This information is not applicable (N/A). This device does not involve machine learning or AI, so there is no "training set." The product is manufactured and tested according to established quality control procedures and standards.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable (N/A) for the same reasons as point 8.
§ 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.