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510(k) Data Aggregation
(139 days)
O'Star Nitrile Examination Gloves Powder Free is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
O'Star Nitrile Examination Gloves Powder Free 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.
This document (K213058) is a 510(k) Premarket Notification for O'Star Nitrile Examination Gloves Powder Free. It primarily focuses on demonstrating substantial equivalence to a predicate device (K210276) through non-clinical performance and biocompatibility testing. The data provided is for the verification and validation of the physical properties and biocompatibility of the gloves, not for an AI/algorithm-based medical device.
Therefore, many of the requested items regarding AI/algorithm performance (e.g., sample size for training set, number of experts for ground truth, MRMC studies, AI assistance effect size) are not applicable to this type of medical device submission.
Here's the breakdown of the information provided in the document concerning the acceptance criteria and the study proving the device meets them:
1. A table of acceptance criteria and the reported device performance:
The document provides two tables in Section VII. PERFORMANCE DATA.
Table 2: Performance Testing Summary - This table details the physical and barrier properties of the gloves.
| SI No. | Tests | Proposed Device actual Data | Acceptance Criteria | Result |
|---|---|---|---|---|
| 1. | Dimension | |||
| Length, Width and Thickness | ||||
| ASTM D6319-19 /ASTM D412-16/ASTM D3767-03-(Reapproved2020) Standard Specification for Nitrile Examination Gloves for Medical Application | Length | |||
| S: 247.2mm | ||||
| M: 243.8mm | ||||
| L: 245.5mm | ||||
| XL: 247.2mm | ||||
| Width | ||||
| S: 90mm | ||||
| M: 103.7mm | ||||
| L: 104.2mm | ||||
| XL: 110.2mm | ||||
| Thickness | ||||
| S: Palm 0.055mm, Finger 0.052mm | ||||
| M: Palm 0.052mm, Finger 0.053mm | ||||
| L: Palm 0.053mm, Finger 0.053mm | ||||
| XL: Palm 0.057mm, Finger 0.053mm | Length | |||
| M: 230mm min | ||||
| (Note: Specific length criteria for S, L, XL are not explicitly listed in the "Acceptance Criteria" column, but based on the "Pass" result and the general ASTM standard, it implies they met standard) | ||||
| Width | ||||
| S: 80mm±10 | ||||
| M: 95mm±10 | ||||
| L: 110mm±10 | ||||
| XL: 120mm±10 | ||||
| Thickness | ||||
| Palm: 0.05 mm min | ||||
| Finger: 0.05 mm min | Pass | |||
| 2. | Physical property | |||
| Tensile strength and Ultimate Elongation | ||||
| ASTM D6319-19/ASTM D573-04 (Reapproved 2019) Standard Specification for Nitrile Examination Gloves for Medical Application | Tensile strength | |||
| Before Aging: | ||||
| S: 14.23 Mpa, M: 15.85 Mpa, L: 14.92 Mpa, XL: 15.32 Mpa | ||||
| After Aging: | ||||
| S: 14.07Mpa, M: 14.09 Mpa, L: 14.13 Mpa, XL: 14.81 Mpa | ||||
| Ultimate Elongation | ||||
| Before Aging: | ||||
| S: 702%, M: 935%, L: 768%, XL: 831% | ||||
| After Aging: | ||||
| S: 694%, M: 836%, L: 728%, XL: 785% | Tensile strength | |||
| Before Aging: 14Mpa Min for all sizes | ||||
| After Aging: 14Mpa Min for all sizes | ||||
| Ultimate Elongation | ||||
| Before Aging: 500% Min for all sizes | ||||
| After Aging: 400%Min for all sizes | Pass | |||
| 3. | Detection of Holes in Medical Gloves | |||
| ASTM D6319-19 /ASTM D5151-19 Standard Test Method for Detection of Holes in Medical Gloves | AQL=2.5 | AQL=2.5 | Pass | |
| 4. | Powder Free Residue | |||
| ASTM D6124-06(Reapproved2017) Standard Test Method for Residual Powder on Medical Gloves | Residual powder content | |||
| S: 0.03 mg | ||||
| M: 0.07 mg | ||||
| L: 0.01 mg | ||||
| XL: 0.05 mg | ≤2 Mg/Glove Max for all sizes | Pass |
Table 3: Biocompatibility Test Summary - This table details the biological safety of the gloves.
| SI. No | Test Performed | Proposed Device | Acceptance Criteria | Result |
|---|---|---|---|---|
| 1. | Invitro Cytotoxicity | Under the conditions of the study, cytotoxic to L-929 cells. Additional Testing was performed to determine if this was a systemic toxicity concern. | Under the conditions of the study, not cytotoxic. | Pass |
| 2. | Skin Sensitization | Under the conditions of the study not a sensitizer. | Under the conditions of the study not a sensitizer. | Pass |
| 3. | Skin Irritation | Under the condition of study not an irritant. | Under the condition of study not an irritant. | Pass |
| 4. | Acute Systemic Toxicity | Under the conditions of the study, the device extracts do not pose a systemic toxicity concern. | Under the conditions of the study, the device extracts do not pose a systemic toxicity concern. | Pass |
2. Sample sizes used for the test set and the data provenance:
- Sample Size for Test Set: The document does not explicitly state the sample sizes (number of gloves) for each physical and biocompatibility test performed. However, for a 510(k) submission, implied sample sizes for such tests typically follow the requirements of the referenced ASTM and ISO standards. These standards specify sample sizes for testing batches of gloves to ensure compliance.
- Data Provenance: The manufacturer's address is listed as "Khac Niem Industrial Cluster, Khac Niem Ward, Bac Ninh City, Bac Ninh Province, Vietnam." This implies the testing was likely conducted in Vietnam or by labs accredited by Vietnamese or international standards, reflecting the country of origin of the data. The data is retrospective, as it was generated from pre-market testing to support the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This question is not applicable as this submission is for a physical medical device (gloves), not an AI/algorithm. Ground truth in this context is established by laboratory measurements according to established international standards (ASTM, ISO).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This question is not applicable for a physical device. Testing results are based on objective measurements and established standards, not human 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:
This question is not applicable as this submission is for a physical medical device (gloves), not an AI/algorithm. No human readers or AI assistance are involved in the performance evaluation of examination gloves.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This question is not applicable as this submission is for a physical medical device (gloves), not an AI/algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the performance of these gloves is established by objective laboratory measurements against predefined international standard specifications (ASTM D6319-19, ASTM D412-16, ASTM D3767-03, ASTM D573-04, ASTM D5151-19, ASTM D6124-06) for physical properties (dimensions, tensile strength, elongation, hole detection, powder residue) and biological testing standards (ISO 10993-1:2018) for biocompatibility (cytotoxicity, skin sensitization, skin irritation, acute systemic toxicity).
8. The sample size for the training set:
This question is not applicable as this submission is for a physical medical device (gloves), not an AI/algorithm. There is no "training set" in the context of device testing for physical properties unless referring to batch manufacturing quality control, which is implied by the adherence to standards.
9. How the ground truth for the training set was established:
This question is not applicable as this submission is for a physical medical device (gloves), not an AI/algorithm.
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