(100 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 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, Powdered vinyl Patient Examination Glove, 80LYZ, Powdered with Absorbable Dusting Powder, USP, and meets all requirements of ASTM Standard D5250-00-4.
The provided text describes a submission for a 510(k) premarket notification for a medical device: Shijiazhuang Hongxiang Plastic Products Co., Ltd. Pre-Powdered Sterile Vinyl Glove, Clear. This submission aims to prove substantial equivalence to a predicate device, not to directly establish efficacy against specific clinical outcomes in an AI/diagnostic context. Therefore, many of the typical questions for an AI/diagnostic device's acceptance criteria and studies (like MRMC studies, effect sizes, specific expert qualifications for ground truth) are not applicable to this type of device and submission.
However, I can extract the relevant "acceptance criteria" (performance standards and test results) and details of the studies conducted to meet those for this specific device.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Standard | Reported Device Performance / Study Finding |
|---|---|
| Physical and Dimensions Testing (ASTM D-5250-00 4) | All testing meets requirements for Physical and Dimensions Testing, Inspection Level S-2, AQL4.0. |
| Pinhole Test (FDA 1000 ml. Water Fill Test based on ASTM D 5151-99) | Samplings of AQL 2.5, Inspection Level I, meeting these requirements. |
| Primary Skin Irritation (Modified Draize Test) | The test material was not irritating to the skin of rabbits. |
| Dermal Sensitization Study (Buehler Method) | An extract of this test material did not appear to produce any skin irritation on guinea pigs. |
| Powder Limit (ASTM D-6124-01) | Insured to meet "powdered" claim (contain no more than 10 mg/dm²). |
| Sterility (ANSI/ISO 11137 standard) | Sterilization dose determined as per method indicated in ANSI/ISO 11137. 25 KGY sterilization dose. Sterilization results conform to the specification of SAL 10⁻⁶. |
| Sterile Packaging (BS EN 868) | Integrity and seal of packaging conform to BS EN 868 sterile packaging requirements. |
Study Details
-
Sample size used for the test set and the data provenance:
- Physical and Dimensions Testing: Sample size is indicated by "Inspection Level S-2, AQL4.0". Actual number of gloves not specified but implied to meet the AQL (Acceptable Quality Level) standard. Data provenance is implied to be from Shijiazhuang Hongxiang Plastic Products Co., Ltd., China.
- Pinhole Test: Sample size is indicated by "AQL 2.5, Inspection Level I". Actual number of gloves not specified but implied to meet the AQL standard. Data provenance is implied to be from Shijiazhuang Hongxiang Plastic Products Co., Ltd., China.
- Biocompatibility (Skin Irritation, Dermal Sensitization): Not specified beyond "rabbits" and "guinea pigs". Data provenance is implied to be from Shijiazhuang Hongxiang Plastic Products Co., Ltd., China, potentially through an external lab (Exhibit #4 is referenced).
- Powder Limit Test: Not specified beyond "finished inspection". Data provenance is implied to be from Shijiazhuang Hongxiang Plastic Products Co., Ltd., China.
- Sterilization Validation: Specific number of products for bioburden determination and sterilization cycle validation not explicitly stated, but methodology follows ANSI/ISO 11137. Data provenance is Radiation Health Research Institute of Hebei Province, China.
- All studies are retrospective as they were conducted prior to the 510(k) submission.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is a device performance and safety study, not a diagnostic accuracy study requiring expert human interpretation as ground truth. The "ground truth" is established by direct measurement against a standard (e.g., amount of powder, number of pinholes, specific biological reactions in test animals).
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. As above, this is not an expert-driven diagnostic accuracy study.
-
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/diagnostic device.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an AI/diagnostic device.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for most of these tests is based on objective measurement against established physical, chemical, and biological standards.
- For physical/dimensional/pinhole tests: Direct measurement/count against ASTM standards.
- For biocompatibility: Observed physiological reaction in animal models (absence of irritation/sensitization).
- For powder limit: Gravimetric analysis against ASTM standard.
- For sterility: Laboratory-determined bioburden and validation through microbial inactivation (SAL 10⁻⁶) according to ANSI/ISO 11137.
- The ground truth for most of these tests is based on objective measurement against established physical, chemical, and biological standards.
-
The sample size for the training set:
- Not Applicable. This is not an AI/machine learning device that requires a training set.
-
How the ground truth for the training set was established:
- Not Applicable. See above.
§ 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.