The Powder Free, Examination Glove is "a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.". (21CFR 880.6250).
This is a disposable device, intended for medical purposes, that is worn on the examiner's hand to prevent contamination between patient and examiner. Examination gloves with protein content labeling are suitable in situations where healthcare worker or patient allergic sensitivity may be a factor. Powder free gloves are intended for use in situations where powder is not desirable.

Device Description

Natural Rubber Latex films form a barrier to body fluids and bloodborne pathogens. The latex rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for medical treatment. Natural Rubber Latex is known to create a barrier to bloodborne pathogens and and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The leaching process removes traces of chemical accelerants that may be chemically irritating. The glove is manufactured in accordance with the requirements of ASTM D3578-95 and ASTM D5151-92 requirements.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Powder Free, Examination Glove, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Specification	Acceptance Criteria (Predicate Device)	Reported Device Performance (Proposed Device)
Performance Standards	ASTM D3578-99	ASTM D3578-99 (identical)
Water Tightness	ASTM D5151-92	ASTM D5151-92 (identical)
Protein Content	ASTM D5712-95	ASTM D5712-95 (identical)
Rabbit Irritation (Safety)	Passes	Passes
Guinea Pig Sensitization (Safety)	Passes	Passes

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

The document does not explicitly state the sample sizes used for the non-clinical tests (e.g., water tightness, protein content) or the clinical tests (rabbit irritation, guinea pig sensitization). It only indicates that these tests were performed and the proposed device "Passes" or meets the specified ASTM standards.

Data provenance is not specified. It's implied that the tests were conducted for the purpose of this 510(k) submission, suggesting prospective testing (for the proposed device) and potentially a mix of internal testing or external lab testing.

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

This information is not applicable and not provided in the document. The tests performed are objective, standardized laboratory tests (e.g., ASTM standards for mechanical properties, animal models for safety) that do not rely on expert consensus for establishing ground truth in the same way a diagnostic imaging study would.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. The tests described are objective measurements and standardized animal studies, not requiring adjudication of human interpretations.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic devices that involve human interpretation of medical images or other complex data. The device in question is an examination glove, and its performance is evaluated through physical and safety testing, not human reader interpretation.

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

Yes, a standalone performance evaluation was done for the device. The reported performance metrics (tensile properties, water tightness, protein content, irritation, sensitization) are inherent characteristics of the glove itself, measured directly without human intervention or interpretation that would constitute a "human-in-the-loop" scenario in a diagnostic context.

7. The Type of Ground Truth Used

The ground truth used for this device's evaluation is based on:

Established Industry Standards: ASTM D3578-99, ASTM D5151-92, and ASTM D5712-95. These standards define the acceptable physical and performance characteristics for examination gloves.
Safety Endpoints from Animal Models: "Passes" results for Rabbit Irritation and Guinea Pig Sensitization, indicating that the device did not cause an unacceptable adverse reaction in these standardized biological tests.

8. The Sample Size for the Training Set

This information is not applicable and not provided. The device (examination glove) is not an AI/ML algorithm that requires a "training set" of data. Its performance is evaluated directly through physical and biological testing.

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

This information is not applicable and not provided, as there is no training set for this type of device.

Summary

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510/K) SUBMISSION FOR POWDER FREE EX SUBMISSION DATE: MAY, 1

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------SUMMARY OF 510(k) Submission # K

A. INFORMATION

ﺤﺘﺎﺑ

SUBMITTER'S NAME:

ADDRESS:

TELEPHONE NUMBER:

CONTACT PERSON:

DATE SUMMARY PREPARED:

1. NAME OF DEVICE TRADE OR PROPRIETARY NAME:
  COMMON OR USUAL NAME:

CLASSIFICATION NAME:

1. PREDICATE DEVICE IDENTIFICATION NAME, NUMBER

TILLOTSON HEALTHCARE CORPORATION

360 Route 101

Bedford, NH 03110 U.S.A.

(603) 472-6600

Thomas N Tillotson

May, 1997

Powder Free, Examination Glove (with protein content labeling claim)

Examination Glove

Powder Free, Examination Glove K974065 (with protein content labeling claim)
DESCRIPTION OF DEVICE

a. HOW THE DEVICE FUNCTIONS: Natural Rubber Latex films form a barrier to body fluids and bloodborne pathogens.
b. SCIENTIFIC CONCEPTS THAT FORM THE BASIS FOR THE DEVICE: The latex rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for medical treatment.

c. PHYSICAL AND PERFORMANCE CHARACTERISTICS SUCH AS DESIGN, MATERIALS AND PHYSICAL PROPERTIES: Natural Rubber Latex is known to create a barrier to bloodborne pathogens and and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The leaching process removes traces of chemical accelerants that

may be chemically irritating. The glove is manufactured in accordance with the requirements of ASTM D3578-95 and ASTM D5151-92 requirements.

HO
I

Section N {Page 1) SUMMARY OF 510(k) SUBMISSION ISO9001\510K\ACTUV.XLS

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SUMMARY OF SAFETY AND EFFECTIVENESS (cont.)

1. STATEMENT OF INTENDED USE, INCLUDING DESCRIPTION OF THE DISEASES OR CONDITIONS THAT THE DEVICE WILL ADDRESS
- This is a disposable device, intended for medical purposes, that is worn on the examiner's hand to prevent contamination between patient and examiner. Examination gloves with protein content labeling 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 is not desirable.
1. EXPLANATION OF SIMILARITIES OR DIFFERENCES TO PREDICATE DEVICE
- · The proposed product is identical to the predicate product and is suitable for situations where a powder free glove is desirable.
  - . It is powder free, (with protein content labeling claim) in the same way as predicate product.
1. IF SE DECISION BASED ON PERFORMANCE DATA
- 1. DISCUSSION OF NON-CLINICAL TESTS

SPECIFICATION	PROPOSEDPowder Free	PREDICATEPowder Free
	(with protein content)	(with protein content)
PERFORMANCESTANDARDS	ASTM D3578-99	ASTM D3578-99
WATER TIGHTNESSPROTEIN	ASTM D5151-92ASTM D5712-95	ASTM D5151-92ASTM D5712-95
DISCUSSION OF CLINICAL TESTS
SPECIFICATION	PROPOSED	PREDICATE
SAFETYRABBIT IRRITATION	Passes	Passes
GUINEA PIG SENSITIZATION	Passes	Passes

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SUMMARY OF SAFETY AND EFFECTIVENESS (cont.)

DISCUSSION OF SAFETY OR EFFECTIVENESS DATA OBTAINED with specific reference to adverse effects and complications

1. CONCLUSIONS DRAWN FROM NONCLINICAL AND CLINICAL TESTS THAT DEMONSTRATE SAFETY EFFECTIVENESS, AND PERFORMANCE =/> PREDICATE PRODUCT
  The Powder Free, Examination Glove has been carefully compared to legally marketed devices in the 510(k). The data summaries indicate that the proposed product meets or exceeds acceptable scores for the predicate product in nonclinical tests, and satisfies the requirements for a safe and effective powder free, (with labeled protein content) medical glove.

Pursuant to 21 C.F.R. 807.87 ( j ), l, Thomas N Tillotson, President certify that to the best of my knowledge and belief and based upon the data and information submitted to me in the course of my responsibilities as the President for TILLOTSON HEALTHCARE CORPORATION, and in reliance thereupon, the data and information submitted in this premarket notification are truthful and accurate and that no facts material to a review of the substantial equivalence of this device have been knowingly omitted from this submission.

Thomas N Tillotson

Thomas N III
President

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing health, human services, and well-being. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 9 1999

Tillotson Healthcare Corporation C/O Ms. Carole Stamp TUV Product Service 1775 Old Highway 8 NW, Suite 104 New Brighton, Minnesota 55112-1891

Re : K992428 Accutouch Powder Free Natural Rubber Latex Trade Name: Patient Examination Glove, Non-sterile Regulatory Class: I Product Code: LYY July 19, 1999 Dated: Received: July 21, 1999

Dear Ms. Stamp:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of

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Page 2 - Ms. Stamp

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in yitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-1041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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3.0 Indications for Use Statement: Include the following or equivalent Indications for Use page. The information, data and labeling claims in the entire 510(k) submission must support and agree with the Indications for Use statement.

INDICATIONS FOR USE

Applicant Tillotson Healthcare 510(k) Number (if known) Device Name: Powder Free Natural Rubber Latex Patient Examination Glove

Indications For Use:

The Powder Free, Examination Glove is "a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.". (21CFR 880.6250).

(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) (Optional Format 1-2-96) OR

Over-The- Counter Use

Qlin S. Lin

(Division Sign-Off) Division of Dental, Infection Control and General Hospita

510(k) Number K992428

Section F (page 2) (3) INDICATIONS FOR USE ISO9001\REGUL\510KNACTUV.XLS

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.