(107 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamingtion between healthcare personnel and the patient's body, fluids, waste or environment.
A patient examination glove is disposable device intended for medical a purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder Free Vinyl Synthetic Examination Gloves with Aloe Vert Creen Color, 80 LYZ, and meets all requirements of ASTM standard D-5250-00E4.
The provided text describes a 510(k) summary for "Ever Light Plastic Products Co., Ltd. Powder Free Vinyl Synthetic Examination Gloves with Aloe Vera, Green Color." This document is focused on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance criteria through a study in the way one would for diagnostic or therapeutic devices.
Therefore, many of the typical acceptance criteria and study details requested (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable in this context. This is a Class I medical device (patient examination glove), which typically requires demonstrating adherence to recognized standards and biocompatibility, not clinical performance studies with specific statistical metrics like sensitivity or specificity.
Here's a breakdown of the information that is available based on your request, highlighting where information is not applicable or not provided in the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard / Test) | Reported Device Performance |
|---|---|
| ASTM D-5250-00E4 (Physical and Dimensions) | Meets all requirements for physical and dimensions testing. (Inspection level S-2, AQL 4.0) |
| FDA 1000 ml. Water Fill Test (Pinhole/Barrier Integrity) | Meets requirements. (Sampling AQL 2.5, inspection level I) |
| Primary Skin Irritation Test | Results showed no primary skin irritant reactions. |
| Skin Sensitization Test (Allergic Contact Dermatitis) | Results showed no sensitization reactions. |
| ASTM D-6124-01 (Residual Powder) | Meets "powder-free" claims (contains no more than 2 mg powder per glove). |
| Biocompatibility Requirements | Meets biocompatibility requirements (specifically mentioned in conclusions, likely supported by the skin irritation/sensitization tests). |
| Labeling Claims | Meets labeling claims (no special claims, not hypoallergenic). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size:
- For ASTM-D-5250-00E4 (Physical & Dimensions): Inspection level S-2, AQL 4.0. (Specific number of gloves not stated, but defined by the inspection level and AQL for lot acceptance).
- For FDA 1000 ml. Water Fill Test: Sampling AQL 2.5, inspection level I. (Specific number of gloves not stated, but defined by the inspection level and AQL for lot acceptance).
- For Primary Skin Irritation and Skin Sensitization: Not specified (usually involves a number of human subjects or animal models, but specific count not provided).
- For Residual Powder Test: Not specified (usually involves a number of gloves from a batch, but specific count not provided).
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective clinical data). Given it's a device manufactured in China (Ever Light Products Co., Ltd. is based in Hebei, China), the testing would likely have been conducted by the manufacturer or a contracted lab to meet international and US standards. The studies described are non-clinical, related to product quality and safety characteristics, not clinical performance in a patient population.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- This is not applicable. The ground truth for these types of tests (physical properties, barrier integrity, biocompatibility) is established by the specifications of the ASTM standards and FDA test methods, not by expert consensus on clinical findings. For example, a pinhole is a physical hole, not an interpretation.
4. Adjudication Method for the Test Set
- This is not applicable. Adjudication methods like 2+1 or 3+1 are used for interpreting ambiguous clinical cases, often in diagnostic imaging. The tests described here have objective pass/fail criteria based on measured physical or chemical properties.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. An MRMC study is relevant for diagnostic devices where human readers interpret data (e.g., medical images). This document describes examination gloves, which do not involve human interpretation in this manner.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No. This question is also not applicable as it pertains to AI/algorithm performance. The device is a physical product (gloves).
7. The Type of Ground Truth Used
- The ground truth used is based on objective standards and test methods:
- ASTM Standard D-5250-00E4: Defines acceptable physical dimensions and properties.
- FDA 1000 ml. Water Fill Test: Defines acceptable barrier integrity (absence of pinholes).
- Primary Skin Irritation and Skin Sensitization testing protocols: Define methods and criteria for evaluating biocompatibility.
- ASTM D-6124-01: Defines acceptable levels of residual powder.
- Biocompatibility principles: Informed by scientific understanding of material interaction with the body.
8. The Sample Size for the Training Set
- This is not applicable. The device is not an AI/ML algorithm or diagnostic tool that requires a "training set." The testing described relates to quality control and meeting product standards.
9. How the Ground Truth for the Training Set Was Established
- This is not applicable for the reasons stated in 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.