(44 days)
A glove is worn on the hand of healthcare 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 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, Vinyl Patient Examination Glove, 80LYZ, Powdered with Absorbable Dusting Powder, USP, Class III and meets all requirements of ASTM Standard D5250-92.
Acceptance Criteria & Study Analysis for K974151: Vinyl Patient Examination Gloves
This device, the Shanghai Super Gloves Co., Ltd. Vinyl Patient Examination Gloves - Powdered, is a Class I medical device (21 CFR 880.6250) and is substantially equivalent to predicate devices. The safety and effectiveness are established through compliance with existing industry standards and specific tests, not through clinical trials in the traditional sense, as there are no specific claims requiring such studies (e.g., hypoallergenic).
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance | Comments |
|---|---|---|---|
| Physical and Dimensions | ASTM-D-5250-92 | Meets requirements | Evaluated at Inspection Level S-2, AQL 4.0 |
| Barrier Integrity (Pinhole Defects) | FDA 1000 ml. Water Fill Test | Meets requirements | Evaluated with samplings of AQL 2.5, Inspection Level S-4 |
| Biocompatibility (Skin Irritation) | Not explicitly stated (standard test) | No primary skin irritant reactions | |
| Biocompatibility (Skin Sensitization) | Not explicitly stated (standard test) | No sensitization (allergic contact dermatitis) reactions | |
| Manufacturing Quality | FDA's Good Manufacturing Practices (GMPs) | Operates in compliance with GMPs | Confirms adherence to quality systems |
| Labeling | Applicable CFR 21 labeling requirements | Conforms fully | No special labeling claims (e.g., hypoallergenic) |
2. Sample Sizes Used for the Test Set and Data Provenance
- Physical and Dimensions: The document states "Inspection Level S-2, AQL 4.0". This refers to attributes sampling plans defined in standards like ISO 2859 (or MIL-STD-105E from which it is derived).
- AQL (Acceptable Quality Level) 4.0: This means that the statistical sampling plan is designed to accept lots where the percentage of defective items is 4.0% or less.
- Inspection Level S-2: This is a special inspection level for circumstances where smaller sample sizes are desired, usually for testing that is destructive or expensive, while still providing some protection. The exact sample size would depend on the batch size, but for S-2, it would be significantly smaller than general inspection levels.
- Barrier Integrity (Pinhole Defects): The document states "samplings of AQL 2.5, Inspection Level S-4".
- AQL 2.5: This means the sampling plan is designed to accept lots where the percentage of defective items is 2.5% or less.
- Inspection Level S-4: Similar to S-2, this is a special inspection level for reduced sample sizes.
- Biocompatibility: No specific sample sizes for these tests are provided in the summary. Standardized tests (e.g., ISO 10993 series which often includes these tests) would typically specify the number of animals or human subjects (for patch tests) required, but the summary only provides the results.
- Data Provenance: The device is manufactured by Shanghai Super Gloves Co., Ltd. in Shanghai, China. The testing was conducted by the manufacturer, or by a testing laboratory on behalf of the manufacturer, to demonstrate compliance with the stated standards. The document does not specify if the data is retrospective or prospective, but given it's for a 510(k) submission, it would reflect tests performed for this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable in the traditional sense for this device.
- For these types of devices (examination gloves), "ground truth" is established by adherence to recognized industry standards (ASTM-D-5250-92 for physical properties, FDA 1000 ml water fill test for pinholes, and general biocompatibility testing standards). The "experts" involved are the certified testing laboratories and their personnel who conduct these standardized tests according to established protocols and interpret the results against the defined acceptance criteria.
- There would not be a panel of human experts establishing a subjective "ground truth" for each glove.
4. Adjudication Method for the Test Set
- Not Applicable. As "ground truth" is based on objective, standardized tests against specified criteria, there is no need for expert adjudication. The tests yield definitive results (e.g., pass/fail for pinholes, quantitative measurements for physical properties, presence/absence of irritation for biocompatibility) which are then compared directly to the acceptance criteria.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. This type of study is not relevant or applicable for an examination glove. MRMC studies are typically used to evaluate diagnostic imaging devices or algorithms where human readers interpret medical images.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Not Applicable. This is not an algorithmic or AI-enabled device. Its performance is intrinsic to its physical and chemical properties.
7. Type of Ground Truth Used
- Objective Test Results against Established Standards: The ground truth for this device is based on objective measurements and observations derived from standardized tests. Examples include:
- Physical Properties: Measurements of dimensions, tensile strength, elongation, etc., compared against the specifications in ASTM-D-5250-92.
- Pinhole Detection: Direct observation using the FDA 1000 ml Water Fill Test.
- Biocompatibility: Clinical observation of skin reactions in standardized animal or human patch tests, interpreted against established criteria for irritation and sensitization.
- The "ground truth" here is the direct, measurable compliance with these recognized benchmarks.
8. Sample Size for the Training Set
- Not Applicable. This device does not involve machine learning or AI, and therefore does not have a "training set" in the computational sense. The manufacturing process is designed to consistently produce gloves that meet the specifications, and quality control sampling is an ongoing process, not a "training set."
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. No training set exists for this 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.