(48 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 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, Power-Free Nitrile Examination Gloves, Blue, 80 LZA, and meets all requirements of ASTM standard D-6319-00a (2005).
The provided text describes the 510(k) summary for the Hong Xin Rubber Products Co., Ltd. Powder Free Nitrile Examination Gloves, Blue. This document is a premarket notification for a Class I medical device, which is typically a low-risk device. For such devices, clinical studies and complex performance evaluations, as you've outlined, are generally not required. Instead, the focus is on demonstrating substantial equivalence to a predicate device through non-clinical testing and adherence to recognized standards.
Therefore, many of the requested sections (2-9) are not applicable to this type of submission.
Here's a breakdown based on the provided document:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| ASTM D-6319-00a (2005) - Physical and Dimensions Testing (Inspection level S-2, AQL 4.0) | "All testing meets requirements for physical and dimensions testing conducted on gloves." |
| FDA 1000 ml. Water Fill Test (AQL 2.5, inspection level G-1) | "meeting these requirements." (Implies meeting pinhole requirements) |
| Primary Skin Irritation Testing | "results showing no primary skin irritant or sensitization reactions." |
| Skin Sensitization (allergic contact dermatitis) Testing | "results showing no primary skin irritant or sensitization reactions." |
| ASTM D-6124-06 - Residual Powder Test (for "powder-free" claim: ≤ 2 mg powder per glove) | "our gloves meet our “powder-free” claims (contain no more than 2 mg powder per glove)." |
| Biocompatibility Requirements (not explicitly detailed, but stated as met) | "meets biocompatibility requirements" |
| Applicable 21 CFR references (not explicitly detailed, but stated as met) | "conform fully to... applicable 21 CFR references" |
2. Sample size used for the test set and the data provenance
- Physical and Dimensions Testing (ASTM D-6319-00a): Inspection level S-2, AQL 4.0. The exact sample size is not stated but is determined by the AQL (Acceptable Quality Level) and inspection level for lot sizes as defined in the ASTM standard.
- FDA 1000 ml. Water Fill Test: Inspection level G-1, AQL 2.5. The exact sample size is not stated but is determined by the AQL and inspection level for lot sizes.
- Primary Skin Irritation and Skin Sensitization Testing: Not specified.
- Residual Powder Test (ASTM D-6124-06): Not specified.
- Data Provenance: Not explicitly stated, but assumed to be from internal testing conducted by Hong Xin Plastic Products Co., Ltd. within China. This is a retrospective analysis of manufacturing quality control data and specific biocompatibility tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The ground truth for this device is established by objective engineering and chemical standards, not expert clinical interpretation.
4. Adjudication method for the test set
Not applicable. The tests involve objective measurements and pass/fail criteria against established standards, not subjective 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
Not applicable. This is not an AI-powered diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI-powered diagnostic device.
7. The type of ground truth used
The ground truth used for this device is based on recognized industry standards (ASTM) and regulatory requirements (FDA pinhole test, 21 CFR). This includes:
- Defined specifications for physical properties (e.g., dimensions, tensile strength).
- Objective measurement criteria for defect levels (AQL for pinholes).
- Established procedures for biocompatibility (skin irritation and sensitization).
- Quantifiable limits for residual powder.
8. The sample size for the training set
Not applicable. This device does not use machine learning or AI, so there is no concept of a "training set." Performance is based on manufacturing quality control and specific material testing.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of device.
§ 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.