(93 days)
This glove is to be worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
Glove, Patient Examination, Vinyl Powder Free
The provided document describes the acceptance criteria and performance data for "Shijiazhuang HongRay Plastic Products Co., Ltd. Vinyl Patient Examination Gloves (Powder Free)."
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
| SPECIFICATION CATEGORY | SPEC (Acceptance Criteria) | REPORTED DEVICE PERFORMANCE (Example for size "Small" where applicable) | Test Code |
|---|---|---|---|
| Material & Physical Properties | |||
| Standard Compliance | Meets all requirements of ASTM Standard D5250-92 | Meets ASTM Standards | - |
| Pinhole Rate | Under 4% pinhole rate | Meets pinhole requirements (Implied to be under 4%) | FDA GLOVE 1000 HL WATER LEAK TEST |
| Tensile Strength (MPa) | Min. 10.0 MPa (for all sizes) | Min. 10.0 MPa (for Small, Medium, Large, X-Large) | JIS-2045.5.2 |
| Elongation (Min.) | 350% (for all sizes) | 350% (for Small, Medium, Large, X-Large) | JIS-2045.5.2 |
| Thickness (Finger Tip) | 0.08mm ± 0.02mm | 0.08mm ± 0.02mm | - |
| Thickness (Cuff) | 0.09mm ± 0.02mm | 0.09mm ± 0.02mm | - |
| Thickness (Palm) | 0.15mm ± 0.02mm | 0.15mm ± 0.02mm | - |
| Dimensional Specifications | |||
| Circumference of Palm (inch) | 6-3/4 (Small), 7-3/4 (Medium), 8-1/2 (Large), 9 (X-Large) | 6-3/4 (Small), 7-3/4 (Medium), 8-1/2 (Large), 9 (X-Large) | JIS-S-2045.5.9 |
| Total Length (± 5H/H) | 240 (Small), 245 (Medium, Large, X-Large) | 240 (Small), 245 (Medium, Large, X-Large) | JIS-S-2045.5.9 |
| Length of Thumbs (H/H) | 55 (Small), 57 (Medium), 61 (Large), 63 (X-Large) | 55 (Small), 57 (Medium), 61 (Large), 63 (X-Large) | JIS-2045.5.9 |
| Length of Index Finger (H/H) | 66 (Small), 70 (Medium), 75 (Large), 78 (X-Large) | 66 (Small), 70 (Medium), 75 (Large), 78 (X-Large) | - |
| Length of Middle Finger (H/H) | 74 (Small), 81 (Medium), 88 (Large), 92 (X-Large) | 74 (Small), 81 (Medium), 88 (Large), 92 (X-Large) | - |
| Length of Ring Finger (H/H) | 69 (Small), 74 (Medium), 79 (Large), 82 (X-Large) | 69 (Small), 74 (Medium), 79 (Large), 82 (X-Large) | - |
| Length of Little Finger (H/H) | 54 (Small), 55 (Medium), 60 (Large), 62 (X-Large) | 54 (Small), 55 (Medium), 60 (Large), 62 (X-Large) | - |
| Circumference of Thumb (H/H) | 63 (Small), 71 (Medium), 78 (Large), 83 (X-Large) | 63 (Small), 71 (Medium), 78 (Large), 83 (X-Large) | JIS-S-2045.5.9 |
| Circumference of Index Finger (H/H) | 56 (Small), 64 (Medium), 70 (Large), 74 (X-Large) | 56 (Small), 64 (Medium), 70 (Large), 74 (X-Large) | - |
| Circumference of Middle Finger (H/H) | 59 (Small), 68 (Medium), 72 (Large), 76 (X-Large) | 59 (Small), 68 (Medium), 72 (Large), 76 (X-Large) | - |
| Circumference of Ring Finger (H/H) | 56 (Small), 63 (Medium), 69 (Large), 73 (X-Large) | 56 (Small), 63 (Medium), 69 (Large), 73 (X-Large) | - |
| Circumference of Little Finger (H/H) | 50 (Small), 57 (Medium), 62 (Large), 66 (X-Large) | 50 (Small), 57 (Medium), 62 (Large), 66 (X-Large) | - |
| Other | |||
| Weight (g/pc) | 7.0 (Small), 8.0 (Medium), 9.0 (Large), 9.5 (X-Large) ± 0.2% | 7.0 (Small), 8.0 (Medium), 9.0 (Large), 9.5 (X-Large) ± 0.2% | - |
| Inner Surface | Powder Free | Powder Free | - |
| Biocompatibility | Primary Dermal Irritation and Guinea Pig Sensitization | Performed by Consumer Products Testing Co., USA. (Results not explicitly stated, but implies acceptance) | - |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated in the provided documents. The specifications are listed for four sizes (Small, Medium, Large, X-Large), implying testing across these different sizes. For quality assurance like "Pinhole Rate," it mentions "FDA GLOVE 1000 HL WATER LEAK TEST," suggesting testing a sample of 1000 gloves but not specifying if this is the sample size for the regulatory submission itself.
- Data Provenance: The document does not explicitly state "test set" data provenance for all tests. The manufacturing location is Shijiazhuang, China. Biocompatibility testing was conducted by "Consumer Products Testing Co., USA." It's retrospective testing of manufactured products to ensure compliance with standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the device is a medical glove, and the "ground truth" is established through physical and chemical testing against established standards (e.g., ASTM, JIS), not through expert interpretation of images or clinical data.
4. Adjudication method for the test set:
This information is not applicable for physical and biocompatibility testing of a medical glove. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in diagnostic studies involving image interpretation or clinical expert review.
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:
This is not applicable. The device is a patient examination glove, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This is not applicable. The device is a patient examination glove, not a standalone algorithm.
7. The type of ground truth used:
The ground truth is established by industry standards and test methods. Specifically:
- ASTM Standard D5250-92
- JIS-S-2045 (various sections for dimensions and tensile properties)
- FDA GLOVE 1000 HL WATER LEAK TEST for pinholes
- Biocompatibility methods (Primary Dermal Irritation in Rabbits and Guinea Pig Sensitization (Buehler))
8. The sample size for the training set:
This information is not applicable. The device is a physical product, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established:
This information is not applicable as 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.