(10 days)
Not Found
No
The device description and performance studies focus solely on the physical properties and barrier function of a medical examination glove, with no mention of AI or ML technologies.
No
The device, an examination glove, is intended to prevent contamination between patient and examiner, not to provide therapy or treat a medical condition.
No
The device, an examination glove, is intended to prevent contamination between patient and examiner, not to diagnose any medical conditions.
No
The device is a physical glove made of natural rubber latex, not software. The description focuses on material properties, manufacturing standards, and physical performance tests.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner." This describes a barrier device for protection, not a device used to examine specimens derived from the human body for diagnostic purposes.
- Device Description: The description focuses on the physical properties of the glove as a barrier (water tight, tensile properties, barrier to bloodborne pathogens and body fluids). It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances in specimens
- Providing information for diagnosis, monitoring, or treatment decisions based on specimen analysis.
- Performance Studies: The performance studies discussed are related to the physical integrity of the glove (water tightness, tensile properties) and safety (irritation, sensitization). There are no studies related to diagnostic accuracy or performance metrics like sensitivity, specificity, etc., which are typical for IVDs.
In summary, the device is a medical glove intended for barrier protection, not for performing in vitro diagnostic tests.
N/A
Intended Use / Indications for Use
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).
Product codes (comma separated list FDA assigned to the subject device)
LYY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner / Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical tests were conducted to compare the proposed device with the predicate device based on:
- PERFORMANCE STANDARDS: ASTM D 3578-00a (Proposed) vs. ASTM D 3578-99 (Predicate)
- WATER TIGHTNESS: ASTM D5151-99 (Proposed) vs. ASTM D5151-99 (Predicate)
Clinical tests were conducted to assess safety based on:
- RABBIT IRRITATION: Passes (Proposed) vs. Passes (Predicate)
- GUINEA PIG SENSITIZATION: Passes (Proposed) vs. Passes (Predicate)
The conclusions drawn were 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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]
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
-
NA
-
PRI
| NAME: | TILLOTSON HEALTHCARE CORPORATION |
|---|---|
| ADDRESS: | 360 Route 101 |
| Bedford, NH 03110 U.S.A. | |
| TELEPHONE NUMBER: | (603) 472-6600 |
| CONTACT PERSON: | Thomas N Tillotson |
| DATE SUMMARY PREPARED: | April 18, 2001 |
| NAME OF DEVICE | |
| TRADE OR PROPRIETARY NAME: | Cymunvera Powder Free Green Natural |
| Rubber LatexExamination Gloves lined with | |
| Aloe Vera | |
| COMMON OR USUAL NAME: | Examination Glove |
| CLASSIFICATION NAME: | Examination Glove |
| PREDICATE DEVICE IDENTIFICATION | |
| NAME, NUMBER | 1. Accutouch Powder Free Natural Rubber |
| Latex 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
1
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
-
- 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.
- STATEMENT OF INTENDED USE, INCLUDING DESCRIPTION OF THE DISEASES OR CONDITIONS THAT THE DEVICE WILL
-
- 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
- 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.
-
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 | |
| PERFORMANCE | ||
| STANDARDS | ASTM D 3578-00a | ASTM D 3578-99 |
| WATER TIGHTNESS | ASTM D5151-99 | ASTM D5151-99 |
| 2. DISCUSSION OF | ||
| CLINICAL TESTS | ||
| SPECIFICATION | ||
| SAFETY | PROPOSED | PREDICATE |
| RABBIT IRRITATION | ||
| GUINEA PIG | Passes | |
| Passes | Passes | |
| Passes |
DISCUSSION OF SAFETY OR EFFECTIVENESS DATA OBTAINED with specific reference to adverse effects and complications
2
-
- 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.
- CONCLUSIONS DRAWN FROM NONCLINICAL AND CLINICAL TESTS THAT DEMONSTRATE SAFETY EFFECTIVENESS, AND PERFORMANCE =/> PREDICATE PRODUCT
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
4
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:
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).
(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.