The 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.

Device Description

Tactyl's powder free examination gloves are manufactured using TACTYLON™. TACTYLON™ gloves are made of a synthetic material that mimics latex but contain no natural rubber latex. It is also powder free for those users who will benefit from such requirements. The glove meets the physical property requirements of ASTM 3578-91 Rubber Examination Gloves. The 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.

AI/ML Overview

This document is a 510(k) summary for a Powder Free Examination Glove, seeking substantial equivalence to a previously marketed device. It does not describe a study involving an AI or algorithm-based device, but rather a physical medical device (examination gloves). Therefore, many of the requested fields related to AI/algorithm performance are not applicable.

Here's the relevant information from the provided text, structured according to your request where applicable:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Physical property requirements of ASTM 3578-91 (Rubber Examination Gloves)	Meets these requirements. Physical properties remain comparable to TACTYLON™ examination gloves.
FDA test for water tightness (21 CFR 800) using 1000 ml water	Passed.
Acceptable Quality Level (AQL) of 4.0 for water tightness (21 CFR 800)	Passed.
Biocompatibility: No delayed dermal sensitization (Guinea Pig - Repeated Patch Method)	Showed no evidence of causing delayed dermal sensitization.
Biocompatibility: Not a primary skin irritant (New Zealand white albino rabbit - Primary Skin Irritation Test (FHSA))	Demonstrated not to be a primary skin irritant.

Note: The document states "The physical properties of the glove remain well within the requirements established by ASTM 3578 and remain comparable to TACTYLON™ examination gloves," but does not provide specific numerical values for each physical property.

Additional Information (Addressing fields where applicable for a physical device)

Sample size used for the test set and the data provenance:
- Water Tightness Test: The document states gloves must pass an AQL of 4.0, which implies a sampling plan from production batches, but the specific sample size for a given test is not provided.
- Biocompatibility Tests: Sample sizes for the animal studies (Guinea Pig and Rabbit) are not specified.
- Provenance: This is a submission by TACTYL TECHNOLOGIES, INC. in the USA. The tests were likely conducted in a laboratory setting to evaluate the product.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for the performance of a physical examination glove is determined by established physical, chemical, and biological testing methods, not by expert interpretation like in image analysis or diagnostic AI.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Results from physical/biological tests are objective measurements based on defined protocols, not subject to opinion-based adjudication.
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 document describes a physical medical device (gloves), not an AI or algorithm.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for this device's performance is based on:
- Standardized Test Methods: Adherence to ASTM (American Society for Testing and Materials) standards for physical properties and FDA regulations (21 CFR 800) for water tightness.
- Animal Biocompatibility Studies: Results from established protocols for delayed contact sensitization and primary skin irritation using animal models.
The sample size for the training set: Not applicable. "Training set" is a concept for machine learning algorithms. This document is about a physical manufacturing process and product testing.
How the ground truth for the training set was established: Not applicable.

Summary

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K955464

TACTYL TECHNOLOGIES, INC.

2595 COMMERCE WAY
VISTA, CA 92083
TEL. (619) 598-2233
FAX (619) 598-1012

ICATF

Powder Free Examination Glove 510(k) Summary DUPL

A. SUBSTANTIAL EQUIVALENCE:

Substantial equivalence is shown by comparing the subject device, a powderfree examination glove, to a previously marketed device with 510(k) clearance. The following information is submitted in compliance of a 510(k) summary as required by 21 CFR 807.92

1. Submitted by:(& Manufactured by)	Tactyl Technologies, Inc.2595 Commerce WayVista, CA 92083	APR 25 1996
Date Prepared:	12 April, 1996
2. Facility Registration:Classification Name:Common Name:Proprietary Name:	202792180LYYPowder Free Examination GloveTACTYLON™ Powder Free Examination Glove
3. Substantially EquivalentDevice:	TACTYLON™ Examination Glove [510(k) K905109]
4. Marketed by:	Tactyl Technologies, Inc.2595 Commerce WayVista, CA 92083
	Other firms may market the product under aprivate label agreement and sell under theirown brand, one such firm is:
	SmartCare3400 East McDowellPhoenix, AZ 85008-7899
5. Device Class:	I
6. Contact Person:	Jorge HaiderDirector of Regulatory Affairs & Quality Assurance

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B. DEVICE DESCRIPTION:

Tactyl's powder free examination gloves are manufactured using TACTYLON™ . TACTYLON™ gloves are made of a synthetic material that mimics latex but contain no natural rubber latex. It is also powder free for those users who will benefit from such requirements. The glove meets the physical property requirements of ASTM 3578-91 Rubber Examination Gloves. The 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.

C. COMPARISON TO TACTYLON™ EXAMINATION GLOVE:

The powder free glove has dramatically reduced powder levels from its equivalent, TACTYLON™ examination glove. The powder free glove has an added coat of material that is treated to provide donning characteristics without having to use corn starch. The physical properties of the glove remain well within the requirements established by ASTM 3578 and remain comparable to TACTYLON™ examination gloves.

The product is tested to and has passed the FDA test for water tightness using 1000 ml of water as called for in 21 CFR 800. This test requires gloves to be mounted on a test fixture and 1000 ml of water must be added. Leakage is defined as water escaping through the glove in any area of the glove, except the top 1½ inches that is attached to the mounting fixture. Any leakage occurring after two minutes is considered a failure. Gloves must pass an Acceptable Quality Level (AQL) of 4.0 as defined in 21 CFR 800.

D. CLINICAL AND NON-CLINICAL TESTING AND THEIR CONCLUSIONS:

Various biocompatibility tests were successfully performed. Delayed Contact Sensitization Study (Repeated Patch Method) was performed in the Guinea Pig and showed no evidence of causing delayed dermal sensitization in the guinea pig. Another test conducted was the Primary Skin Irritation Test (FHSA) in the New Zealand white albino rabbit The test demonstrated the glove not to be a primary skin irritant.

Jorge Haider
Jorge Haider
Date
12 April 96

Director of Regulatory Affairs and Quality Assurance

Regulation Number and Section

§ 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.