(238 days)
A patient exammation glove is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.
Two subject devices are bundled into this 510(k) submission. The first is a Hycare Med+ Nitrile Examination Gloves, blue colored, non-sterile called Hycare Med+ Nitrile Examination Gloves and the second is Hycare Touch Latex Examination Gloves, Natural White, Non-Sterile with Protein Labeling Claim (50 ug/g or less) called Hycare Touch Latex Examination Gloves.
The principal operation both types of patient exam gloves are to provide single use barrier protection for the wearer and each device meets all the appropriate requirement specifications for Barrier Protection and tensile properties as defined in ASTM D6319-10, Standard Specification for Nitrile Examination Gloves and ASTM D3578-19, Standard Specification for Rubber Examination Gloves.
The following models are disposable, single-use examination gloves (in boxes of 50, 100 and 200) which are included in this submission:
Hycare Touch Latex Examination Gloves: Latex examination gloves non-sterile powder-free polymer coated (Ambidextrous) – palm textured, Color: Natural white, Sizes: XS, S, M, L, XL
Hycare Med+ Nitrile Examination Gloves: Nitrile examination gloves non-sterile powder-free (Ambidextrous) - Finger textured, Color: Blue, Sizes: S, M, L, XL, XXL
This is a 510(k) premarket notification for medical gloves, specifically "Hycare Med+ Nitrile Examination Gloves" and "Hycare Touch Latex Examination Gloves." The document describes non-clinical testing performed to demonstrate substantial equivalence to predicate devices. Clinical performance testing was explicitly stated as "N/A Not applicable for this device."
Therefore, this response will focus on the non-clinical testing results as they relate to acceptance criteria.
1. Table of Acceptance Criteria and Reported Device Performance
Let's present the tables for each device separately.
Device Candidate #1: Hycare Med+ Nitrile Examination Gloves
| Test Title | Acceptance Criteria | Reported Device Performance | Met Acceptance Criteria? |
|---|---|---|---|
| ASTM D6319-10 Standard Specification for Nitrile Examination Gloves for Medical Application | |||
| Tensile Strength (Physical Properties) | Before Aging: 14 MPa min; After Aging: 14 MPa min | Met acceptance criteria after Aging at 70°C for 168 hrs @ 100°C for 22 hrs | Yes |
| Elongation (Physical Properties) | Before Aging: 500% Elongation min; After Aging: 400% Elongation min | Met acceptance criteria after Aging at 70°C for 168 hrs @ 100°C for 22 hrs | Yes |
| ASTM D5151 Standard Test Method for detection of Holes in Medical Gloves | Inspection level G-1, AQL 2.5, reject max of 22 samples | 19 rejects detected, under 22 by AQL standards | Yes |
| D6124-06 Standard Test Method for Residual Powder on Medical Gloves | Residue limit 10% in control. 3. No mortality or abnormal behavior in control. | No mortality or morbidity observed, gradual increase in body weight and no signs of ill health or toxicity was observed | Yes |
Device Candidate #2: Hycare Touch Latex Examination Gloves
| Test Title | Acceptance Criteria | Reported Device Performance | Met Acceptance Criteria? |
|---|---|---|---|
| ASTM D3578-19 Standard Specification for Rubber Examination Gloves | |||
| Tensile Strength (Physical Properties) | Before Aging: 18 MPa min; After Aging: 14 MPa min | Met acceptance criteria after Aging at 70°C for 168 hrs @ 100°C for 22 hrs | Yes |
| Elongation (Physical Properties) | Before Aging: 650% Elongation min; After Aging: 500% Elongation min | Met acceptance criteria after Aging at 70°C for 168 hrs @ 100°C for 22 hrs | Yes |
| Stress at 500% Elongation | 5.5 MPa max | Met acceptance criteria after Aging at 70°C for 168 hrs @ 100°C for 22 hrs | Yes |
| ASTM D5151 Standard Test Method for detection of Holes in Medical Gloves | Inspection level G-1, AQL 2.5 | 13 rejects detected, under 22 by AQL standards | Yes |
| D6124-06 Standard Test Method for Residual Powder on Medical Gloves | Residue limit 10% in control. 3. No mortality or abnormal behavior in control. | No mortality or morbidity observed, gradual increase in body weight and no signs of ill health or toxicity was observed | Yes |
Note About ISO 10993-5 Cytotoxicity: Both devices "failed" the cytotoxicity test, meaning they were cytotoxic at undiluted extraction. However, the FDA's "Comments" section for both devices states "Different" for this characteristic when comparing to the predicate, with the predicate often not having conducted this specific testing. This suggests that the FDA accepted the submission despite this finding, likely based on the overall safety profile, established use of similar materials, or the specific application of the device (e.g., short-term skin contact).
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the exact sample sizes for each test set (e.g., number of gloves tested for physical properties, number of animals for biocompatibility tests). However, for the Freedom from Pinholes (ASTM D5151) test, it mentions:
- Hycare Med+ Nitrile Examination Gloves: 19 rejects detected, under 22 by AQL standards. (This implies a sample size that would yield an AQL of 2.5 and an inspection level of G-1, allowing for a maximum of 22 defects for acceptance).
- Hycare Touch Latex Examination Gloves: 13 rejects detected, under 22 by AQL standards. (Similarly implies a sample size based on AQL 2.5, inspection level G-1).
The data provenance (country of origin of the data, retrospective or prospective) is not explicitly stated. The submitting company, Hycare International Co., Ltd., is located in Thailand, which suggests the testing may have been conducted there or by affiliated labs. The testing appears to be prospective as it's part of a submission for a new device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable and not provided in the document. The tests performed are standardized, objective physical and chemical tests (e.g., tensile strength, pinholes, residual powder) and in vitro or in vivo biocompatibility tests, which do not typically involve human expert consensus for "ground truth" in the way a diagnostic imaging AI would.
4. Adjudication Method for the Test Set
Not applicable. The tests are scientific measurements or biological assays with specific pass/fail criteria from the standards, not subjective assessments requiring adjudication.
5. 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 comparative effectiveness study involving human readers or AI. It is a premarket notification for general medical gloves.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device does not involve an algorithm or AI.
7. The Type of Ground Truth Used
The "ground truth" is established by adherence to the specified ASTM and ISO international standards themselves. These standards prescribe methodologies and acceptance criteria for various physical, chemical, and biological properties. For example:
- Physical Properties (Tensile Strength, Elongation): Measured values against numerical thresholds defined in ASTM D6319-10 and ASTM D3578-19.
- Freedom from Pinholes: Statistical sampling and defect limits based on AQL (Acceptable Quality Level) defined in ASTM D5151.
- Residual Powder: Measured mass against a numerical threshold (2.0 mg/dm²) defined in D6124-06.
- Biocompatibility (Irritation, Sensitization, Systemic Toxicity): Observed biological responses in test subjects/cells against control groups or established thresholds for reactivity/toxicity, as per ISO 10993-10 and ISO 10993-11.
- Cytotoxicity: Cell viability/response against specified grading criteria in ISO 10993-5.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" as this is not a machine learning or AI device.
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no training set, this question is not relevant.
§ 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.