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This is a disposable device, intended for medical purposes, that is worn on the examiner's hand to prevent contamination between patient and examiner.

Hypoallergenic patient examination gloves are sultable in situations where healthcare worker or patient allergic sensitivity may be a factor.

Powder free gloves are intended for use in situations where powder should not be used.

Device Description

Patient examination gloves are made with an intact natural latex rubber film, which provides a barrier to body fluids and bloodborne pathogens, and between patient and examiner.

AI/ML Overview

The provided text describes a 510(k) submission for the "Ultra Care Powder Free Hypoallergenic Non-Sterile Patient Exam Glove." This is a medical device, and the submission focuses on demonstrating its substantial equivalence to predicate devices, rather than a typical clinical study proving disease-related performance.

Therefore, the requested information elements (especially those related to "AI," "radiologist," "MRMC," "training set," "adjudication," "effect size," and "outcomes data") are not applicable to this type of device submission. The acceptance criteria and "study" described here pertain to the physical properties, safety, and hypoallergenic nature of a glove, not a diagnostic or therapeutic AI-driven device.

Here's an adaptation of the requested information based on the provided text, focusing on the relevant aspects for this medical device submission:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for this type of device are primarily based on demonstrating equivalence to predicate devices for physical properties and safety.

Feature	Acceptance Criteria (Equivalence to Predicate)	Reported Device Performance (Ultra Care Powder Free Hypoallergenic NS Patient Exam Glove)
Physical Properties
Water Tightness	Identical specifications to Predicate Product #1 (Formula One Patient Exam Glove K891939). Results of testing must demonstrate equivalence. Adherence to ASTM standards where applicable.	"The specifications for both gloves are identical with respect to water tightness and all physical parameters such as tensile and elongation. Results of testing demonstrate equivalence." (Section A.6)
Tensile Strength	Identical specifications to Predicate Product #1. Results of testing must demonstrate equivalence.	"..."parameters such as tensile and elongation. Results of testing demonstrate equivalence." (Section A.6)
Elongation	Identical specifications to Predicate Product #1. Results of testing must demonstrate equivalence.	"..."parameters such as tensile and elongation. Results of testing demonstrate equivalence." (Section A.6)
Formulation
Latex Formulation	Identical formulation for the latex layer as Predicate Product #1.	"The formulation for the latex layer is identical in the proposed and predicate #1 gloves." (Section A.6)
Safety & Biocompatibility
Hypoallergenic	Must pass a Modified Draize Repeat Insult Patch Test on human subjects, demonstrating a lack of sensitization, similar to Predicate Product #2 (Sensi Shield Glove Kit, Inner Glove, K910383).	"Both Predicate #2 and Proposed product have passed a Modified Draize Repeat Insult Patch Test on human subjects, and have been found hypoallergenic." (Section A.6). "Under the conditions employed in this study, there was no evidence of sensitization" (Section B.2).
Rabbit Skin Irritation	Must meet acceptable scores/standards for safety, similar to predicate products. Standard biological evaluation criteria for medical devices.	The summary states, "The data summaries indicate that the proposed product meets acceptable scores for the predicate products in physical, nonclinical and clinical tests." (Section B.3)
Guinea Pig Sensitization	Must meet acceptable scores/standards for safety, similar to predicate products. Standard biological evaluation criteria for medical devices.	The summary states, "The data summaries indicate that the proposed product meets acceptable scores for the predicate products in physical, nonclinical and clinical tests." (Section B.3)

2. Sample Sizes Used for the Test Set and Data Provenance

Hypoallergenic Test (Modified Draize Repeat Insult Patch Test):
- Sample Size: 300 human subjects.
- Data Provenance: Retrospective, from "three different locations" (implied US-based, as this is a US regulatory submission).
Physical Property Tests (Water Tightness, Tensile, Elongation):
- Sample Size: Not explicitly stated for the "results of testing," but samples would have been drawn from manufacturing lots.
- Data Provenance: Retrospective, from internal product testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Hypoallergenic Test: The "Modified Draize Repeat Insult Patch Test" involves clinical evaluation by medical professionals (e.g., dermatologists or clinicians specializing in allergy/irritation). The specific number and qualifications of the conducting/evaluating experts are not provided, but it's implied to be a standard clinical test procedure.
Physical Property Tests: Ground truth is established by standardized test methods (e.g., ASTM standards) and direct measurement, not expert consensus.

4. Adjudication Method for the Test Set

Hypoallergenic Test: No explicit adjudication method (like 2+1) is described for the human subject patch test. The "no evidence of sensitization" conclusion implies a direct observation by the clinical evaluators.
Physical Property Tests: Not applicable, as it involves direct measurement against specified standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is not applicable for a patient examination glove. This type of study is typically used for diagnostic imaging devices where human readers interpret medical images.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in the sense that the device itself was tested directly. The tests for water tightness, tensile strength, elongation, and the Modified Draize Repeat Insult Patch Test directly evaluated the glove's performance as a standalone product. There is no "algorithm" or human-in-the-loop component for this device.

7. The Type of Ground Truth Used

Physical Properties: Objective measurements against pre-defined specifications and ASTM standards.
Hypoallergenic Test: Clinical observation and evaluation by medical professionals in a controlled human subject test, demonstrating the absence of sensitization (a form of clinical ground truth).
Safety (Rabbit Skin Irritation, Guinea Pig Sensitization): Biological test results against established safety criteria.

8. The Sample Size for the Training Set

Not applicable. This submission is for a physical medical device, not an AI/ML algorithm. There is no "training set." The product's manufacturing process and formulation are established, and subsequent testing (as described above) confirms the final product characteristics.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set for an AI/ML model, this question does not apply. The "ground truth" for the device's design and manufacturing is derived from established engineering principles, material science, and regulatory standards for medical gloves.

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