(105 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 contamination between healthcare personnel and the patient's body. fluids, waste or environment.
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880.6250)
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirement of ASTM Standard D5250-00.
The provided text describes a 510(k) submission for "Tangshan Zhongying Plastic Products Co., Ltd. Synthetic Vinyl Patient Examination Gloves - Powder Free". This submission focuses on medical device regulatory clearance based on substantial equivalence, rather than a clinical study evaluating AI algorithms. Therefore, much of the requested information (e.g., sample size for test/training sets, number of experts for ground truth, MRMC study, AI effect size) is not applicable to this document.
However, I can extract the acceptance criteria and reported device performance related to the physical and biological characteristics of the gloves.
Here's the relevant information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Description | Reported Device Performance |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ASTM D5250-00 Compliance | The gloves must meet all requirements of ASTM Standard D5250-00, which specifies requirements for polyvinyl chloride patient examination gloves. This standard includes various physical property tests (e.g., tensile strength, elongation at break), dimensions, and freedom from holes. | "All testing meets requirements for Physical and Dimensions Testing conducted on gloves." and "conform fully to ASTM-D-5250-00 standard" |
| Physical and Dimensions Testing | Based on ASTM-D-5250-00 standard, with Inspection Level S-2, AQL 2.5. This implies specific sampling plans and acceptable quality limits for defects. | "All testing meets requirements for Physical and Dimensions Testing conducted on gloves, Inspection Level S-2. AOL 2.5." |
| Freedom from Holes (Pinhole FDA Requirements) | Assessed using the FDA 1000 ml. Water Fill Test. The acceptance criteria for this test specify a maximum acceptable quality level (AQL) for pinholes. | "The FDA 1000 ml. Water Fill Test was also conducted with samplings of AOL 2.5, Inspection Level I, meeting these requirements" and "meets pinhole FDA requirements." |
| Primary Skin Irritation | The objective is to ensure the gloves do not cause significant skin irritation. | "Primary Skin irritation...testing was conducted with results showing no primary skin irritant or sensitization reactions." |
| Skin Sensitization (Allergic Contact Dermatitis) | The objective is to ensure the gloves do not cause allergic reactions or sensitization. | "Skin Sensitization (allergic contact dermatitis) testing was conducted with results showing no primary skin irritant or sensitization reactions." |
| Powder-Free Claim | The gloves must contain no more than 2 mg powder per glove to meet the "powder-free" claim. | "testing...is conducted to insure that our gloves meet our 'powder-free' claims (contain no more than 2 mg powder per glove)." |
| Biocompatibility | General biocompatibility requirements. | "meets...biocompatibility requirements" |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document mentions "samplings of AOL 2.5, Inspection Level I" for the Water Fill Test and "Inspection Level S-2. AOL 2.5" for Physical and Dimensions Testing. This refers to a statistically defined sampling plan (ANSI/ASQ Z1.4 typically used for AQL), but the absolute number of units sampled is not explicitly stated. The sample size would depend on the batch size being tested.
- Data Provenance: The tests were conducted on the manufacturer's gloves, Tangshan Zhongying Plastic Products Co., Ltd., which is based in Hebei, China. The data is prospective in the sense that these tests were performed on the device manufactured for submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This document describes the testing of physical and biological properties of gloves, not evaluation of medical imaging or diagnostic algorithms requiring expert interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. As above, this is not relevant to the type of testing performed on examination gloves.
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:
- No. This is a medical device clearance for examination gloves, not an AI or imaging diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. This device does not involve an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- For physical and dimensional testing, the "ground truth" (or reference standard) is established by the definitions and specifications within the ASTM D5250-00 standard.
- For the Water Fill Test (pinholes), the ground truth is defined by the FDA 1000 ml water fill test method and its pass/fail criteria.
- For skin irritation and sensitization, the ground truth is based on standard toxicological testing protocols and evaluation for adverse reactions.
- For powder content, the ground truth is determined by a **quantitative gravimetric test method (
§ 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.