(217 days)
A glove is wom on the hand of healtcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste, or environment
Latex Patient Examination glove (Hypoallergenic) 50 micrograms or less of total water extractable protein per gram of glove
This is a 510(k) summary for a latex patient examination glove, not a software device employing AI. Therefore, most of the requested information (like sample size for test/training sets, data provenance, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies) is not applicable.
However, I can extract the acceptance criteria and the "device performance" (as described in the document as "SPECIFICATION") for the glove, along with the studies mentioned for safety and basic quality.
Acceptance Criteria and Device Performance for Siam Sempermed Latex Patient Examination Glove (Hypoallergenic)
1. Table of Acceptance Criteria and Reported Device Performance
| DESCRIPTION | Acceptance Criteria (ASTM standard where applicable) | Reported Device Performance (SPECIFICATION) |
|---|---|---|
| DIMENSION | S-2 AQL 4.0 | S-2 AQL 4.0 |
| Overall length | 230 mm MIN. | 240 +/- 10 mm |
| Width (double wall) | S 80 +/- 10 mm, M 95 +/- 10 mm, L 111 +/- 10 mm | SS 77 +/- 5 mm, S 83 +/- 5 mm, M 94 +/- 5 mm, L 105 +/- 4 mm |
| Thickness, mm | ||
| Finger | 0.08 mm MIN. | 0.08 mm MIN. |
| Palm | 0.08 mm MIN. | 0.08 mm MIN. |
| PHYSICAL PROPERTIES | S-2 AQL 4.0 | S-2 AQL 4.0 |
| Before aging | ||
| Tensile strength | 14 Mpa MIN. | 14 Mpa MIN. |
| Elongation at break | 700 % MIN. | 700 % MIN. |
| After aging | ||
| Tensile strength | 14 Mpa MIN. | 14 Mpa MIN. |
| Elongation at break | 500 % MIN. | 500 % MIN. |
| WATER EXTRACTABLE PROTEIN | N/A (ASTM standard not specified for this) | S-2 AQL 4.0, 50 ug/g MAX. |
| POWDER LEVEL | N/A (ASTM standard not specified for this) | 2.5 +/- 1.0 by weight |
| FREEDOM FROM HOLE | S-4 AQL 4.0 | II AQL 1.5 |
| Additional Properties | ||
| Outer surface | Free from talc (Magnesium silicate) (Implicit acceptance: meets this statement) | Free from talc (Magnesium silicate) |
| Hypoallergenic claim | 50 micrograms or less of total water extractable protein per gram of glove (Implicit acceptance: meets this statement) | 50 micrograms or less of total water extractable protein per gram of glove |
Study Demonstrating Device Meets Acceptance Criteria
The document refers to a general statement that the device "meet or exceed the ASTM standard or equivalent standard meet pinhole FDA requirements meet labeling claims". This implies that internal quality control and testing validated these specifications against the stated ASTM standards.
Specific studies mentioned not directly for the performance table above, but for safety and claims, include:
- Human Repeat Insult Patch Test: Concordia Research Laboratories, Inc. Study Number. SAT-001
- Finding: "From the complete lack of reactions noted during the Elicitation Phases (Challenge) of this test, it is evident that the irritation and allergenic potential of the test article is extremely low, If existent at all It is the opinion of the undersigned that this product can be safely distributed for its intended use". This supports the "Hypoallergenic" claim and safety for intended use.
- Primary Dermal Irritation in Rabbits / Guinea Pig Sensitization (Buehler): Consumer Product Testing Co. Experiment reference number T95-0189-1.
- Finding: "According to Federal Hazardous Substances Act Regulations, (16 CFR 1500.41), and under the conditions of this test, this test article is not a primary dermal irritant". This supports the safety of the device.
Non-Applicable Information for this Device (Medical Glove)
The following information requested in the prompt is not applicable to this type of device (a latex patient examination glove, not an AI software device):
- Sample size used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
- Adjudication method for the test set.
- If a multi reader multi case (MRMC) comparative effectiveness study was done.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc).
- The sample size for the training set.
- How the ground truth for the training set was established.
These questions are relevant for AI/software devices that analyze data (like medical images), not for a physical product like a glove where performance is typically assessed through physical and chemical testing against established standards.
§ 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.