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The subject device is a patient examination glove made of a synthetic nitrile latex compound. It is non-sterile, powder-free, with a polymer inner coating of aloe and Vitamin E (per 21 CFR 880.6250, Class I). The device can be either white or pink in color. The device is ambidextrous and can be worn on either the left or right hand. The device meets ASTM D6319-10: Standard Specification for Nitrile Examination Gloves for Medical Application.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Non-Sterile, Powder Free Nitrile Examination Gloves with Polymer Coating, Aloe, Vitamin E, White and Pink device, extracted from the provided document:

Acceptance Criteria and Device Performance

The device is a medical glove, and its performance is evaluated against established ASTM standards and general guidelines for medical gloves.

Table 1: Acceptance Criteria and Reported Device Performance

Characteristics	Acceptance Criteria/Standards	Reported Device Performance (Subject Device K142685)
Indications for Use	Medical Glove Guidance Manual	This is a medical device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Device Design	-	A protective garment that covers the hand and wrist with openings for fingers and thumb.
Material	ASTM D6319-10	Nitrile Synthetic latex
Single Use	Medical Glove Guidance Manual	Single use
Ambidextrous	Medical Glove Guidance Manual	Ambidextrous
Sterility	Not applicable	Not applicable
Dimensions	ASTM D6319-10	Meets ASTM D6319-10 - Overall Length: 220 mm min (XS, S), 230 mm min (M, L, XL) - Width (+/- 10 mm): Size XS: 70 mm, Size S: 80 mm, Size M: 95 mm, Size L: 110 mm, Size XL: 120 mm - Thickness: Finger: 0.05 mm min, Palm: 0.05 mm min
Physical Properties	ASTM D6319-10 (aging= 70 +/- 2°C for 166 +/- 2 hrs; 100 +/- 2°C for 22 +/- 0.3 hrs)	Meets ASTM D6319-10 - Tensile Strength: 14 MPa min (before aging), 14 MPa min (after aging) - Ultimate Elongation: 500% min (before aging), 400% min (after aging)
Freedom from Pinholes	ASTM D5151-06	Meets AQL 2.5, Inspection Level G-1
Residual Powder	ASTM D6124-06	<2.0 mg/pc
Color	-	White and Pink
Labeling	Medical Glove Guidance Manual	Draft includes English only and lacks other minor elements pending completion of FINAL design; brand name(s) pending. (Note: Predicate includes English, French, and Spanish).
Biocompatibility	Primary Dermal Irritation in Rabbits and Guinea Pig Closed Patch Sensitization Test (ISO 10993-10)	Under the conditions of these studies, the test article was a non-irritant and non-sensitizer.

Study Information

This document is a 510(k) premarket notification, which demonstrates substantial equivalence to a legally marketed predicate device, rather than an independent clinical study proving new performance. Therefore, many of the typical clinical study details are not directly applicable.

Sample size used for the test set and the data provenance:
- The document does not specify a distinct "test set" in the context of a prospective clinical trial with human subjects. Instead, the device's physical properties are tested according to ASTM standards. The sample sizes for these standard tests (e.g., for dimensions, tensile strength, pinholes) are inherent to the specified ASTM methods, but not explicitly stated in this summary.
- Data Provenance: The testing was conducted by or on behalf of Siam Sempermed Corp., LTD, in Thailand, as indicated by the company's address. The data is retrospective in the sense that it's a summary of completed testing, not a prospective clinical trial.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the context of this 510(k) submission. "Ground truth" for physical properties is established by adherence to the objective criteria defined in the ASTM standards. For biocompatibility, the ground truth is established by the findings of the animal studies.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Performance is measured objectively against specified physical and chemical standards.
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 device is a pair of examination gloves, not an AI-powered diagnostic or assistive tool.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device (gloves).
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the device's performance is based on objective measurements and chemical analyses as defined by the referenced ASTM standards (e.g., D6319-10 for dimensions and physical properties, D5151-06 for pinholes, D6124-06 for residual powder) and ISO standard (10993-10 for biocompatibility).
The sample size for the training set:
- Not applicable. This is not a machine learning or AI device that requires a training set.
How the ground truth for the training set was established:
- Not applicable.

Summary Conclusion from the document:

The provided document, a 510(k) summary, concludes that the subject device is "substantially equivalent" to its predicate device (K121549) based on identical intended use, material, production process, and compliance with the same performance and biocompatibility standards. The only difference noted is the color (White and Pink for the subject device vs. Lavender Blue for the predicate). The "study" here is primarily a series of compliance tests against established industry standards and a comparison to a previously cleared device.

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