(410 days)
A 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.
Powder Free Nitrile Examination Glove, Black and dual color White-Blue are Class 1 Patient Examination Gloves. The dual color White-Blue is made dual color by double dipping. They are ambidextrous and come in different sizes, Extra Small, Small, Medium, Large and Extra Large, Double Extra-Large and Triple Extra-Large.
This document describes the premarket notification (510(k)) for Powder Free Nitrile Examination Gloves (Black and Dual Color White-Blue) from Careplus (M) SDN BHD. This is for an examination glove, a Class I reserved device (21 CFR 880.6250) intended for medical purposes to prevent contamination between patient and examiner.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Standard Reference | Standard Specification | Device Performance (Black Glove) | Device Performance (White-Blue Glove) | Predicate Device Performance |
|---|---|---|---|---|---|
| Product Code | - | LZA, 21 CFR 880.6250 | LZA, 21 CFR 880.6250 | LZA, 21 CFR 880.6250 | LZA, 21 CFR 880.6250 |
| Class | - | I | I | I | I |
| Material | - | Nitrile | Nitrile | Nitrile | Nitrile |
| Color | - | - | Black | White-Blue | Blue, White |
| White Pigment | - | Titanium Dioxide | Titanium Dioxide | Titanium Dioxide | Titanium Dioxide |
| Size | ASTM D6319-19 | - | XS,S,M,L,XL, XXL,XXXL | XS,S,M,L,XL, XXL,XXXL | XS,S,M,L,XL |
| Water Tight Test | ASTM D6319-19, ASTM D5151-06 | G-I, AQL 2.5 | Meets specification | Meets specification | Meets specification |
| Physical Properties (Before Aging) | |||||
| Tensile Strength | ASTM D6319-19 | Min. 14 Mpa | Meets specification (min. 25 Mpa) | Meets specification (min. 25 Mpa) | Meets specification |
| Ultimate Elongation | ASTM D6319-19 | Min. 500 % | Meets specification (min. 605 %) | Meets specification (min. 606 %) | Meets specification |
| Physical Properties (After Aging) | |||||
| Tensile Strength | ASTM D6319-19 | Min. 14 Mpa | Meets specification (min. 29 Mpa) | Meets specification (min. 26 Mpa) | Meets specification |
| Ultimate Elongation | ASTM D6319-19 | Min. 500 % (should be 400 min based on table 6) | Meets specification (min. 559 %) | Meets specification (min. 576 %) | Meets specification |
| Powder Content | ASTM D6319-19, ASTM D6124-06 | Max. 2 mg/glove | Meets specification (Max. 1.02) | Meets specification (Max. 0.90) | Meets specification |
| Biocompatibility Tests | |||||
| Primary Skin Irritation Test | ISO 10993-10 | - | No irritant response | No irritant response | No irritant response |
| Dermal Sensitization Test | ISO 10993-10 | - | No skin sensitization effect | No skin sensitization effect | No skin sensitization effect |
| Acute Systemic Toxicity | ISO 10993-11 | - | No revelation of toxicity | No revelation of toxicity | No revelation of toxicity |
| In vitro Cytotoxicity Test | ISO 10993-5 | Cytotox at undiluted, 1:2 (Black); undiluted, 1:2, 1:4, 1:8 (White-Blue) | Varies by dilution, non-cytotoxic at higher dilutions | Varies by dilution, non-cytotoxic at higher dilutions | Varies by dilution, non-cytotoxic at higher dilutions |
| Freedom from pin-holes | ASTM D6319-19 | AQL 2.5 | 1.5 and below | 1.5 and below | 1.5 and below |
| Dimensions | |||||
| Width, mm | ASTM D6319-19 | XS - 70 ± 10, etc. | Within specification | Within specification | Meet Specification |
| Length, mm | ASTM D6319-19 | XS - 220 min, etc. | Within specification | Within specification | Meet Specification |
| Thickness Palm, mm | ASTM D6319-19 | XS - 0.05 min, etc. | Within specification (e.g., min 0.13) | Within specification (e.g., min 0.15) | Meet Specification |
| Thickness Finger, mm | ASTM D6319-19 | XS - 0.05 min, etc. | Within specification (e.g., min 0.18) | Within specification (e.g., min 0.19) | Meet Specification |
| Single Use | - | Single Use | Single Use | Single Use | Single Use |
| Labeling | - | Single Use | Single Use | Single Use | Single Use |
| Intended Use | - | As defined (medical purposes) | Same as predicate | Same as predicate | Same as predicate |
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 test. Instead, it indicates that the "performance test data from the non-clinical test met the specifications from ASTM testing methodology." ASTM standards for examination gloves (like D6319-19) typically define sampling plans for various tests (e.g., AQL for pinholes).
The data provenance is not specified beyond being generated by the device manufacturer, Careplus (M) SDN BHD, located in Seremban, Negeri Sembilan Darul Khusus, Malaysia. The studies are prospective in the sense that they were conducted to test the performance of the specific subject devices.
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 section is not applicable as the device is an examination glove, not an AI or diagnostic imaging device that requires expert interpretation to establish a "ground truth" for a test set. Its performance is evaluated against physical and chemical specifications and biocompatibility standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable. The performance evaluation for examination gloves typically involves objective measurements and scientific testing against established standards, not subjective adjudication by experts on a test set as would be found in AI/diagnostic studies.
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
This section is not applicable. The device is an examination glove, not an AI-assisted diagnostic tool. Therefore, MRMC studies are irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. The device is a physical product (an examination glove), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established by objective measurements and adherence to recognized international standards such as ASTM D6319-19 (Standard Specification for Nitrile Examination Gloves for Medical Application) and ISO 10993 (Biological evaluation of medical devices for biocompatibility). For example:
- Pin-hole detection is measured against an Acceptable Quality Level (AQL).
- Physical properties like tensile strength, elongation, and dimensions are tested against minimum/maximum values specified in the ASTM standard.
- Biocompatibility is assessed through standardized tests (e.g., skin irritation, sensitization, acute systemic toxicity, in vitro cytotoxicity) as per ISO 10993, with predefined criteria for "no irritant response," "no skin sensitization effect," etc.
8. The sample size for the training set
This section is not applicable. The device is a physical product, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
This section is not applicable 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.