(99 days)
Beijing Reagent Latex Products Co., Ltd. Nitrile Examination Gloves are disposable devices intended for medical purpose that are worn on the examiner's hand to prevent contamination between patient and examiner.
The Beijing Reagent Latex Products Co., Ltd. Nitrile Examination Gloves are powder-free Class I patient examination gloves are manufactured from nitrile and are blue in color. The examination gloves are intended for medical purpose, will be worn on the examiner's hand, and will be available in four sizes (Small, Medium, Large, and Extra-Large).
The provided document describes the acceptance criteria and the results of non-clinical testing for the Beijing Reagent Latex Products Co., Ltd. Nitrile Examination Gloves (K211515).
Here's the breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Test Method (Purpose) | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| ASTM D 6319 Standard Specification for Nitrile Examination Gloves for Medical Application (To determine the length of the gloves) | Small: Min 220 mm | |
| Medium: Min 230 mm | ||
| Large: Min 230 mm | ||
| Extra-Large: Min 230 mm | Pass | |
| ASTM D 6319 Standard Specification for Nitrile Examination Gloves for Medical Application (To determine the width of the gloves) | Small: 80 ± 10 mm | |
| Medium: 95 ± 10 mm | ||
| Large: 110 ± 10 mm | ||
| Extra-Large: 120 ± 10 mm | Pass | |
| ASTM D 6319 Standard Specification for Nitrile Examination Gloves for Medical Application (To determine the Thickness of the gloves) | Min palm thickness: 0.05 mm | |
| Min finger thickness: 0.05 mm (for all sizes) | Pass | |
| ASTM D 5151 Standard Test Method for Detection of Holes in Medical Gloves (To determine the presence of holes in the gloves) | AQL = 2.5 | Pass (Glove inspection passes at an AQL of 2.5) |
| ASTM D 6124 Standard Test Method for Residual Powder on Medical Gloves (To determine the residual powder content on the gloves) | ≤ 2 mg/glove | Pass |
| ASTM D 6319 Standard Specification for Nitrile Examination Gloves for Medical Application (To determine the tensile strength of the gloves) | Before Aging: Minimum of 14 MPa for all Sizes | |
| After Aging: Minimum of 14 Mpa for all sizes | Pass | |
| ASTM D 6319 Standard Specification for Nitrile Examination Gloves for Medical Application (To determine the ultimate elongation of the gloves) | Before Aging: Minimum of 500% for all sizes | |
| After Aging: Minimum of 400% for all sizes | Pass | |
| Biocompatibility: Primary Skin Irritation per ISO 10993-10 (To determine if the finished device material is an irritant) | Not an irritant under the conditions of the study. | Pass |
| Biocompatibility: Dermal Sensitization per ISO 10993-10 (To determine if the finished device material is a sensitizer) | Not a sensitizer under the conditions of the study. | Pass |
| Biocompatibility: In Vitro Cytotoxicity per ISO 10993-5 (To determine if the finished device material is cytotoxic) | Non-cytotoxic under the conditions of the study. (Note: The predicate device listed "cytotoxic. Additional testing performed to determine if this was a systemic toxicity concern." The subject device listed "cytotoxic at elevated test article extracts. Additional analysis was performed to determine if this was a systemic toxicity concern. Non-cytotoxic at 25% test article extract.") | Non-cytotoxic at 25% test article extract. |
| Biocompatibility: Acute Systemic Toxicity Test per ISO 10993-11 (To determine if the finished device material extracts pose a systemic toxicity concern) | Device extracts do not pose a systemic toxicity concern under the conditions of the study. | Pass |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the specific sample sizes used for each non-clinical test. It refers to compliance with ASTM and ISO standards, which typically specify sampling plans. The data provenance is implied to be from the manufacturer's testing of the subject device (Beijing Reagent Latex Products Co., Ltd.), which is located in Beijing, China. The testing appears to be prospective as it was conducted for this specific 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable to the non-clinical tests described. The ground truth for these tests is established by objective physical and chemical testing methods as defined by the ASTM and ISO standards, rather than expert consensus on medical images or clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable to the non-clinical tests described. Adjudication methods are typically used for subjective assessments or when discrepancies arise in expert interpretations of medical data, which is not the case here.
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
A multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The document states, "This section is not applicable to this Premarket Notification 510(k); there was no clinical testing conducted on this product." This device is a medical glove, and its performance is evaluated through physical and biocompatibility testing, not through AI assistance for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a medical glove, not an algorithm or AI-based diagnostic tool. Its performance is entirely standalone in its physical and biological properties.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for these non-clinical tests is based on objective measurements and standardized testing protocols defined by international standards (ASTM and ISO). For example:
- Physical properties (length, width, thickness, tensile strength, elongation) are determined by direct measurement.
- Hole detection is determined by water leak testing.
- Powder residue is determined by gravimetric analysis.
- Biocompatibility tests (skin irritation, sensitization, cytotoxicity, systemic toxicity) are performed in vitro or in vivo according to specified biological testing methods, and the results are compared against defined biological responses.
8. The sample size for the training set
This information is not applicable. The device is a physical product (medical glove), not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set for this 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.