(136 days)
A powder free patient examination glove (Tested for Use with Chemotherapy Drugs) is a disposable device intended for medical purposes that is worn on the examiners hand or finger to prevent contamination between patient and examiner. These gloves are not intended to be used as a chemical barrier.
Shanghai China Star Corp Powder free blue Nitrile Examination Glove is a class I device having product code 80LZA. It is a disposable device powdered with absorbable dusting powder that meets all requirements of ASTM D 631900a-05 and is tested with chemotherapy drugs.
Here's a breakdown of the acceptance criteria and study information for the Shanghai China Star Corp Powder Free Blue Nitrile Patient Examination Glove, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test / Characteristic | Acceptance Criteria (from predicate/standard) | Reported Device Performance (New Device) |
|---|---|---|
| Physical Specifications | ||
| Width (size medium) | 92mm (Predicate K040841) | 92mm |
| Overall length | 240mm (Predicate K040841) | 240mm |
| Palm thickness | 0.17mm (Predicate K040841) | 0.17mm |
| Finger thickness | 0.18mm (Predicate K040841) | 0.18mm |
| Tensile strength pre-aging min | 21mpa (Predicate K040841) | 21mpa |
| Tensile strength after-aging min | 16mpa (Predicate K040841) | 16mpa |
| Ultimate elongation pre-aging min | 500 (Predicate K040841) | 500 |
| Ultimate elongation after-aging min | 500 (Predicate K040841) | 500 |
| Performance Testing | ||
| Dermal Sensitization Test | Passes (Predicate K040841, K022765) | Passes |
| Primary Skin irritation | Passes (Predicate K040841, K022765) | Passes |
| Permeation testing | Not explicitly stated as "Passes" criteria, but ASTM D 6978-05 standard implies expected performance | Passes |
| Iodine Test | Not explicitly stated as "Passes" criteria | Passes |
| Tensile strength (ASTM D6319-00a) | Meets requirements of ASTM D6319-00a | Gloves meet the requirements of ASTM D6319-00a. |
| Barrier strength (ASTM D6319-00a) | Meets requirements of ASTM D6319-00a | Gloves meet the requirements of ASTM D6319-00a. |
| Residual powder test | Passes (Predicate K040841, K022765) | Passes |
| Biocompatibility standards | Yes (Predicate K040841, K022765) | Yes |
| Duration of biocompatibility | Limited (Predicate K040841, K022765) | Limited |
| Pinholes | AQL 2.5 (ASTM D 6319-00a) | AQL 2.5 |
| General Inspection Level | S-2 (ASTM D 6319-00a) | S-2 |
| General AQL for Inspection | AQL 4.0 (ASTM D 6319-00a) | AQL 4.0 |
Study Details:
The provided document describes a 510(k) premarket notification which aims to demonstrate that a new device is substantially equivalent to legally marketed predicate devices. This is a regulatory pathway, not a traditional clinical study designed to "prove" device performance in the same way a randomized controlled trial would. Instead, it relies on demonstrating that the new device meets established standards and performs similarly to predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document repeatedly references "Inspection level S-2, AQL 4.0" and "pinholes at AQL 2.5" as per ASTM D 6319-00a. These are sampling plans for quality control, not a fixed sample size for a "test set" in the context of clinical studies. ASTM D 6319-00a specifies statistical sampling procedures for examination gloves. The exact sample size would depend on the lot size being tested according to the standard.
- Data Provenance: The document does not explicitly state the country of origin for the testing data, although the applicant and manufacturer are based in Shanghai, China. The testing appears to be retrospective in the sense that it's performed on manufactured gloves to demonstrate compliance with standards, rather than a prospective study observing usage in a real-world setting.
3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts
- This information is not applicable (N/A) in this context. The "ground truth" for this device's performance is established by conformance to recognized international standards (ASTM D 6319-00a, ASTM D 6978-05) and comparison to existing predicate devices. There isn't a need for expert consensus on interpreting complex medical images or clinical outcomes here. The tests are objective measurements against defined criteria.
4. Adjudication Method for the Test Set
- N/A. As explained above, this is not a study requiring adjudication of expert opinions or clinical outcomes. The tests are objective and deterministic.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. An MRMC study is typically used for diagnostic imaging devices to assess how human readers' performance with and without AI assistance changes. This document describes examination gloves, which do not involve diagnostic interpretation by human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- N/A. This device is a physical product (gloves), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.
7. The Type of Ground Truth Used
- The "ground truth" used for this device is primarily established industry standards (ASTM D 6319-00a and ASTM D 6978-05) and the performance specifications of legally marketed predicate devices (K040841, K022765). These standards define the acceptable physical properties and performance characteristics (e.g., tensile strength, barrier integrity, biocompatibility).
8. The Sample Size for the Training Set
- N/A. This is not a machine learning or AI device that requires a "training set." The device is a manufactured product tested against defined specifications.
9. How the Ground Truth for the Training Set was Established
- N/A. No training set is involved.
§ 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.