CYMUNVERA POWDER FREE GREEN NATURAL RUBBER LATEX PATIENT EXAMINATION GLOVE LINED WITH ALOE VERA by TILLOTSON HEALTHCARE CORP.

Cymunvera Powder Free Green Natural Rubber Latex Examination Glove lined with Aloe Vera 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).

Device Description

Natural Rubber Latex films form a barrier to body fluids and bloodborne pathogens. The natural rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure. 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 Proteins and chemical accelerants that may be chemically irritating. The glove is manufactured in accordance with the requirements of ASTM D 3578-00a and ASTM D5151-92 requirements. This is a disposable device, intended for medical purposes, that is worn on the examiner's hand to prevent contamination between patient and examiner. Powder free gloves eliminate issues of powder contamination.

AI/ML Overview

This document is a 510(k) submission for the CYMUNVERA Powder Free Green Natural Rubber Latex Patient Examination Glove lined with Aloe Vera. It focuses on demonstrating substantial equivalence to a predicate device, not on proving effectiveness for a specific clinical condition using AI. Therefore, the questions related to AI performance, multi-reader multi-case studies, and human reader improvement are not applicable to this submission.

Here's an analysis of the provided information, focusing on the relevant criteria for a medical glove:

Acceptance Criteria and Device Performance for CYMUNVERA Powder Free Green Natural Rubber Latex Patient Examination Glove

1. Table of Acceptance Criteria and Reported Device Performance:

Specification	Predicate Device Performance	Proposed Device (Cymunvera) Performance
Physical Properties
Powder Free	Powder Free	Powder Free
Color	White Color	Green Color
Performance Standards
ASTM D 3578 (General)	ASTM D 3578-99	ASTM D 3578-00a (Meets/Exceeds)
Water Tightness	ASTM D5151-99	ASTM D5151-99 (Meets/Exceeds)
Safety
Rabbit Irritation	Passes	Passes
Guinea Pig Sensitization	Passes	Passes

Notes on Acceptance Criteria and Performance:

The acceptance criteria are implicitly met by demonstrating performance that is "equal to or exceeds" the predicate device in relevant ASTM standards and safety tests.
The "PROPOSED" column shows that the Cymunvera glove meets or exceeds the predicate's performance against these established standards. Specifically, it states "Passes" for irritation and sensitization, and utilizes a newer version of ASTM D 3578 (D 3578-00a vs D 3578-99) while maintaining the same water tightness standard.
The primary differences highlighted are the color (green vs. white) which is a cosmetic difference and the intended use of the aloe vera lining, which is not directly assessed in this table but is implied to contribute to wearer comfort.

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

The document does not specify sample sizes for the non-clinical tests (e.g., number of gloves tested for water tightness, number of rabbits/guinea pigs used).
The data provenance is not explicitly stated beyond being part of a 510(k) submission by Tillotson Healthcare Corporation, based in Bedford, NH, U.S.A. It is typical for such tests to be conducted in a laboratory setting, often by third-party testing facilities. The tests are prospective in the sense that they were conducted for the purpose of this submission to verify the device's properties.

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

Not applicable. This submission focuses on objective, standardized physical and biological tests for a medical glove, not on expert interpretation of medical images or data. The "ground truth" for these tests is defined by the ASTM standards themselves and the results of the laboratory tests.

4. Adjudication Method for the Test Set:

Not applicable. See point 3. Testing against ASTM standards involves objective measurements, not subjective adjudication by human experts.

5. 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 is a medical glove submission, not an AI/software device. No human-in-the-loop performance or AI assistance is involved.

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

Not applicable. This is a medical glove submission, not an AI/software device.

7. The Type of Ground Truth Used:

The ground truth for the non-clinical tests (physical performance and safety) is based on established industry standards (ASTM D 3578-00a and ASTM D5151-99) and the results of standardized laboratory testing for rabbit irritation and guinea pig sensitization. For example, water tightness is determined by whether the glove passes the specified leak rate test. "Passes" for irritation/sensitization means that the tests did not elicit a reaction above a defined threshold according to the test protocols.

8. The Sample Size for the Training Set:

Not applicable. This product is a physical medical device, not an AI algorithm that requires a training set. The "training" for such a device would refer to its manufacturing process development and quality control, not data-driven learning.

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

Not applicable. See point 8.

Summary

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OCT 1 2 2001

510(K) Sub. - CYMUNVERA Powder Free Green Latex Patient Exam Glove Submission Date: August 27, 2001 510(K) Number:_

[TAB #11]

K013286

ATTACHMENT #9

CYMUNVERA Powder Free Green Natural Rubber Latex Patient Examination Glove lined with Aloe Vera SUMMARY OF 510(k) Submission

INFORMATION A. 1. SUBMITTER'S

NAME:	TILLOTSON HEALTHCARE CORPORATION
ADDRESS:	360 Route 101Bedford, NH 03110 U.S.A.
TELEPHONE NUMBER:	(603) 472-6600
CONTACT PERSON:	Thomas N Tillotson
DATE SUMMARY PREPARED:	April 18, 2001
NAME OF DEVICETRADE OR PROPRIETARY NAME:	Cymunvera Powder Free Green NaturalRubber LatexExamination Gloves lined withAloe Vera
COMMON OR USUAL NAME:	Examination Glove
CLASSIFICATION NAME:	Examination Glove
PREDICATE DEVICE IDENTIFICATIONNAME, NUMBER	1. Accutouch Powder Free Natural RubberLatex Examination Glove K992428

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 natural rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure.
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 Proteins and chemical

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accelerants that may be chemically irritating. The glove is manufactured in accordance with the requirements of ASTM D 3578-00a and ASTM D5151-92 requirements

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. Powder free gloves eliminate issues of powder contamination.
1. EXPLANATION OF SIMILARITIES OR DIFFERENCES TO PREDICATE DEVICE The product has similar properties compared to the predicate product. It is suitable for situations where a powder free, NRL glove is desirable.
  It is green compared to the white color of the predicate product
B. IF SE DECISION BASED ON PERFORMANCE
DATA

SENSITIZATION

DISCUSSION OF NON-CLINICAL TESTS

SPECIFICATION	PROPOSED	PREDICATE
	Powder Free	Powder Free
	Green Color	White Color
PERFORMANCESTANDARDS	ASTM D 3578-00a	ASTM D 3578-99
WATER TIGHTNESS	ASTM D5151-99	ASTM D5151-99
2. DISCUSSION OFCLINICAL TESTS
SPECIFICATIONSAFETY	PROPOSED	PREDICATE
RABBIT IRRITATIONGUINEA PIG	PassesPasses	PassesPasses

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

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1. CONCLUSIONS DRAWN FROM NONCLINICAL AND CLINICAL TESTS THAT DEMONSTRATE SAFETY EFFECTIVENESS, AND PERFORMANCE =/> PREDICATE PRODUCT
  The Cymunvera, 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, natural rubber latex medical glove.

Pursuant to 21 C.F.R. 807.87 ( j ), I, Thomas N Tillotson, CEO, 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 CEO 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. Tilletson

Thomas N Tillotson CEO

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three stripes forming its wing, symbolizing health, services, and people. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 2 2001

Tillotson Healthcare Corporation C/O Mr. Mark Job Responsible Third Party Official TUV Products Service, Incorporated 1775 Old Highway 8 New Brighton, Minnesota 55112-1891

Re: K013286

Trade/Device Name: Cymunvera Powder Free Green Natural Rubber Latex Patient Examination Glove Lined with Aloe Vera Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: October 1, 2001 Received: October 2, 2001

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not

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mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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 regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the and additionally hand (301) 594-4618. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

[signature]

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

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

Applicant:	Tillotson Healthcare Corporation
5 10(k) Number (if known):*	K013286

Cymunvera Powder Free Green Natural Rubber Latex Examination Device Name: Glove lined with Aloe Vera

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH Office of Device Evaluation (ODE)

Qhis S. hm
(Division Sign-Off)

ntal Infection 510(k) Numbe

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

For a new submission, do NOT fill in the 510(k) number blank.

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.