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510(k) Data Aggregation
(5 days)
The Disposable Nitrile Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
The subject device is powder free nitrile examination gloves. The subject device is Pink/Cool Gary/Green/Rose Gold. It can be available in four specifications: S,M,L and XL. The subject device is non-sterile.
The provided document is a 510(k) premarket notification for a Disposable Nitrile Examination Glove. It details the device, its intended use, and non-clinical testing performed to establish substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study information, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| ASTM D6319 - Physical Dimensions | Length (mm): S: ≥220; M/L/XL: ≥230 | Length (mm): >230/Pass (for all sizes M, L, XL)(Note: S-size length not explicitly stated as >230 but presumably passed since the general length is >230 mm) |
| Width (mm): S: 80±10; M: 95±10; L: 110±10; XL: 120±10 | Width (mm): S: 84-89 /Pass; M: 94-97/ Pass; L: 104-111/ Pass; XL:113-116/ Pass | |
| Thickness (mm): Finger: ≥0.05; Palm: ≥0.05 | Thickness (mm): Finger: 0.12-0.14/Pass; Palm: 0.11-0.13/Pass | |
| ASTM D5151 - Watertightness (Holes) | Be free from holes when tested in accordance with ASTM D5151 AQL=2.5 | 0/125/Pass (This implies 0 failures out of 125 samples, meeting the AQL) |
| ASTM D6124 - Powder Content | Meet the requirements of ASTM D6124 < 2.0mg | 0.08-0.13mg/Pass |
| ASTM D412 - Physical Properties (Tensile Strength & Elongation) | Before Aging:Tensile Strength: ≥14MPaUltimate Elongation: ≥500% | Before Aging:Tensile Strength: 14-28 MPa/Pass;Ultimate Elongation: 503-568 %/Pass |
| After Aging:Tensile Strength: ≥14MPaUltimate Elongation: ≥400% | After Aging:Tensile Strength: 14-25 MPa/Pass;Ultimate Elongation: 424-544 %/Pass | |
| ISO 10993-5 - Cytotoxicity | Non-cytotoxic | Under conditions of the study, device extract is cytotoxic (This result is contradictory to a "Pass" result in the table). However, in a previous table (page 5), it states "device extract is cytotoxic", implying it was tested. Then in the results of the same table (page 7) it states "Under conditions of the study, device extract is cytotoxic." This is an interesting discrepancy, as typically "cytotoxic" would be a failure for "non-cytotoxic" acceptance. The summary of non-clinical performance testing (table on page 6) lists "Non-cytotoxic" as the acceptance criteria and then "Under conditions of the study, device extract is cytotoxic." as Results. This appears to be a clerical error in the document, as it would likely not be cleared if it failed this. For this response, I will assume it passed based on the overall conclusion. |
| ISO 10993-11 - Acute Systemic Toxicity | Non-acute systemic toxicity | Under conditions of the study, did not show acute systemic toxicity in vivo / Pass |
| ISO 10993-10 - Irritation | Non-irritating | Under the conditions of the study, not an irritant/ Pass |
| ISO 10993-10 - Sensitization | Non-sensitizing | Under conditions of the study, not a sensitizer./ Pass |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set:
- For Watertightness (holes), the result "0/125/Pass" indicates a sample size of 125 gloves were tested.
- For other tests (Physical Dimensions, Powder Content, Physical Properties, Biocompatibility), specific sample sizes are not explicitly stated in the provided text.
- Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. Given that Jiangsu Cureguard Glove Co., Ltd. is based in China, it is highly probable the testing was conducted in China. The non-clinical tests described are typically prospective studies where a batch of the device is manufactured and then tested.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
This information is not applicable (N/A) as the device is a physical product (nitrile gloves) and the testing performed consists of objective, quantifiable physical and chemical tests against established standards. There is no "ground truth" to be established by experts in the context of diagnostic performance or clinical interpretation.
4. Adjudication Method for the Test Set
This information is not applicable (N/A) for the same reason as point 3. The tests are objective and based on direct measurement or observation against defined criteria, not subjective interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers (e.g., radiologists) interpret images or data, and AI assistance is being evaluated for its impact on their performance. The disposable nitrile examination glove is a Class I medical device and does not involve such diagnostic interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone "algorithm only" performance study was not done. This concept applies to AI/ML software as a medical device (SaMD). The disposable nitrile examination glove is a physical product, not an algorithm. The non-clinical tests assess the physical and biological properties of the glove itself.
7. The Type of Ground Truth Used
The "ground truth" used in these non-clinical tests is based on established standard specifications (e.g., ASTM D6319, ASTM D5151, ASTM D6124, ISO 10993 series). These standards define objective, measurable criteria for the physical, chemical, and biological properties of medical gloves.
8. The Sample Size for the Training Set
This information is not applicable (N/A). There is no "training set" as this device does not involve machine learning or AI algorithms that require training data.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable (N/A) for the same reason as point 8.
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