(99 days)
The Ultra Preserve With Aloe Vera (Green) 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).
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 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 chemical accelerants that may be chemically irritating. The glove is manufactured in accordance with the requirements of ASTM D3578-00 and ASTM D5151-99 requirements.
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Ultra Preserve With Aloe Vera (Green) Natural Rubber Latex Examination Glove:
Summary on Acceptance Criteria and Supporting Studies
This 510(k) submission primarily relies on performance testing against established ASTM standards and comparison to legally marketed predicate devices to demonstrate substantial equivalence. It does not involve a study with human readers or AI, as it is for a medical device (examination glove) where performance is evaluated through material properties and barrier integrity rather than diagnostic interpretation.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Standard/Characteristic | Acceptance Criteria (Predicate) | Reported Device Performance (Proposed) |
|---|---|---|
| Water Tightness | ASTM D5151-99 | ASTM D5151-99 (Meets or Exceeds) |
| Residual Protein | ASTM D5712-99 | ASTM D5712-99 (Meets or Exceeds) |
| Residual Particulate | ASTM D6124-00 | ASTM D6124-00 (Meets or Exceeds) |
| Antigenic Protein | ASTM D6499-00 | ASTM D6499-00 (Meets or Exceeds) |
| Rabbit Irritation | Pass | Pass (Meets or Exceeds) |
| Guinea Pig Sensitization | Pass | Pass (Meets or Exceeds) |
| Protein Content Claim | <= 200 micrograms | <= 200 micrograms |
| Total Particulate per Glove Claim | <= 15 milligrams | <= 15 milligrams |
| General Physical Properties | ASTM D3578-00a / ASTM D3578-99 | ASTM D3578-00a (Meets or Exceeds) |
Note: The document explicitly states: "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, green, aloe vera, no starch donning powder added with 15 milligrams or less of total particulate with protein content labeling claim (200 micrograms or less) per glove and made from Allotex an enzyme treated natural rubber lates claim medical glove."
Regarding point 2 through 9 of your request, the provided 510(k) does not contain information on these aspects because it is not a study involving diagnostic interpretation or human readers, but rather a submission for a physical medical device (examination glove).
However, I will address what one could infer or state based on the type of submission:
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for each test, but standard test methods (ASTM) imply specific sample size requirements. These would involve a statistically significant number of gloves or material samples to ensure representativeness as per the ASTM standards cited (e.g., ASTM D5151-99 for water tightness, ASTM D5712-99 for residual protein).
- Data Provenance: The tests are non-clinical, likely performed in a laboratory setting by the manufacturer (Tillotson Healthcare Corporation) or a contracted testing facility. The document does not specify a country of origin for the data itself beyond the manufacturer's location (Bedford, NH, U.S.A.). It is retrospective in the sense that the tests were completed before the submission date.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. "Ground truth" in this context refers to the defined parameters of the ASTM standards and the test results obtained by validated laboratory methods. There are no "experts" in the sense of clinicians or radiologists establishing ground truth for performance of a glove. The standards themselves are developed by committees of experts in materials science and relevant fields.
4. Adjudication method for the test set:
- Not applicable. Test results are objective measurements against defined performance criteria in the ASTM standards. There is no subjective interpretation requiring adjudication.
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 for an examination glove, not an AI-powered diagnostic device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is for an examination glove, not an algorithm.
7. The type of ground truth used:
- Established physical and chemical properties and performance parameters: The "ground truth" is defined by the requirements of the cited ASTM standards for examination gloves, covering aspects like water tightness, tensile properties, protein content, and particulate matter. Biocompatibility tests (rabbit irritation, guinea pig sensitization) also have defined "pass" criteria.
8. The sample size for the training set:
- Not applicable. There is no "training set" as this is not a machine learning or AI algorithm.
9. How the ground truth for the training set was established:
- Not applicable. There is no "training set" or "ground truth" in the context of an algorithm. For the glove's manufacturing, the "ground truth" for quality control would be the manufacturing specifications and raw material standards based on the final product's required performance.
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510(k) Sub. - Ultra Preserve With Aloe Vera (Green) Natural Rubber Latex Examination Glove Made from Allotex an enzyme treated natural rubber latex with a Protein Content Claim of 200 micrograms or less with 15 milligrams or less of Total Particulate per Glove. Submission Date: April 2002 510(k) Number:
[TAB #13]
5 2002 JUL
Attachment #11
Summary of 510(k) Submission
A. INFORMATION
- SUBMITTER'S ﺎﺳﻢ NAME:
TILLOTSON HEALTHCARE CORPORATION
Bedford, NH 03110 U.S.A.
360 Route 101
(603) 472-6600
F.W. Perrella
April 2002
| ADDRESS: |
|---|
| ---------- |
TELEPHONE NUMBER:
CONTACT PERSON:
DATE SUMMARY PREPARED:
- NAME OF DEVICE
TRADE OR PROPRIETARY NAME:
Ultra Preserve With Aloe Vera (Green) Natural Rubber Latex Examination Glove Made from Allotex® an enzyme treated natural rubber latex with a Protein Content Claim of 200 micrograms or less with 15 milligrams or less of Total Particulate per Glove.
| COMMON OR USUAL NAME: | |
|---|---|
| ----------------------- | -- |
Examination Glove
CLASSIFICATION NAME:
NAME, NUMBER
Examination Glove
- PREDICATE DEVICE IDENTIFICATION
a. Ultra Care Natural Rubber Latex Examination Gloves Made from Allotex® an enzyme treated natural rubber latex with a Protein Content Claim of 200 micrograms or less with 15 milligrams or less of Total Particulate per Glove. (K002718) b. Ultra Care (GREEN) Natural Rubber Latex Examination Gloves (K982505)
c. CymunVera Powder Free GREEN Natural Rubber Latex Exmination Gloves Lined with ALOE VERA (K013286)
4. DESCRIPTION OF DEVICE
- HOW THE DEVICE FUNCTIONS: ટ્વ. Natural Rubber Latex films form a barrier to body fluids and bloodborne pathogens.
- SCIENTIFIC CONCEPTS THAT FORM THE BASIS FOR THE DEVICE: b. 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 a medical procedure.
- ﻥ ﻧ PHY SICAL AND PERFORMANCE CHARACTERISTICS SUCH AS DESIGN,
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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 D3578-00 and ASTM D5151-99 requirements.
-
STATEMENT OF INTENDED USE, INCLUDING DESCRIPTION OF THE DISEASES OR 5. 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 suitable in situations where healthcare worker or patient allergic sensitivity may be a factor. -
EXPLANATION OF SIMILARITIES OR DIFFERENCES TO PREDICATE DEVICE ર. The modified product has a raw material change whereby the inner surface of the glove is treated with Aloe Vera and the natural rubber latex is treated with Green pigment compared to the predicate product.
B. IF THE DECISION BASED ON PERFORMANCE DATA DISCUSSION OF NON-CLINICAL TESTS 1.
| SPECIFICATION | PROPOSED | PREDICATE |
|---|---|---|
| Same as predicatebut with a Greencolor and Aloe Veralabeling claims. | Ultra Care synthetic inner coating with nostarch donning powder added with Proteinand Particulate Content labeling Claims andMade from Allotex an enzyme treatednatural rubber latex claim. (K002718) | |
| Same Green color aspredicate but withAloe vera, Proteinand particulateContent labelingClaims and Madefrom Allotex anenzyme treatednatural rubber latexclaim | Ultra Care synthetic inner coating with nostarch donning powder added and with apowder content labeling claim and GREENcolorant labeling claim. (K982505) | |
| Same Aloe Veracontaining aspredicate but withMade from Allotexan enzyme treatednatural rubber latexclaim | Cymun Vera Green synthetic inner coatingwith no starch donning powder added andwith an Aloe Vera content labeling claim andGreen colorant labeling claim. (K013286) |
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510(k) Sub. - Ultra Preserve With Aloe Vera (Green) Natural Rubber Latex Examination Glove Made from Allotex® an enzyme treated natural rubber latex with a Protein Content Claim of 200 micrograms or less with 15 milligrams or less of Total Particulate per Glove. Submission Date: April 2002 510(k) Number: K K ASTM D3578-99 ASTM D3578-00a
| PERFORMANCESTANDARDS | ASTM D3578-00a | ASTM D3578-99 |
|---|---|---|
| WATER TIGHTNESS | ASTM D5151-99 | ASTM D5151-99 |
| RESIDUAL PROTEIN | ASTM D5712-99 | ASTM D5712-99 |
| RESIDUAL PARTICULATE | ASTM D6124-00 | |
| ANTIGENIC PROTEIN | ASTM D6499-00 | |
| DISCUSSION OF CLINICALTESTS | ||
| SPECIFICATIONSAFETY | PROPOSED | PREDICATE |
| RABBIT IRRITATION | PASS | |
| GUINEA PIG SENSITIZATION | PASS |
DEDEODA (ANDD
- CONCLUSIONS DRAWN FROM NONCLINICAL AND CLINICAL TESTS THAT DEMONSTRATE 3. SAFETY EFFECTIVENESS, AND PERFORMANCE =/> PREDICATE PRODUCT
The Ultra Preserve, 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, green, aloe vera, no starch donning powder added with 15 milligrams or less of total particulate with protein content labeling claim (200 micrograms or less) per glove and made from Allotex an enzyme treated natural rubber lates claim medical glove
Pursuant to 21 C.F.R. 807.87 ( j ), I, F.W. Perrella, Ph.D., Vice President R&D 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 V.P. R&D for TILLOTSON HEALTHCARE CORPORATION, and in reliance thereupon, the data and information submitted in this of the substantial equivalence of this device have been knowingly omitted from this Submission.
F.W. Perrella, Ph.D. Vice President R&D
R.M. Panella
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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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
JUL 5 2002 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Frank W. Perrella Vice President, Research and Development Tillotson Healthcare Corporation 360 Route 101 Bedford, New Hampshire 03110
Re: K021007
Trade/Device Name: Ultra Preserve with Aloe Vera (Green) Natural Rubber Latex Examination Gloves made from Allotex® an enzyme treated natural rubber latex with a Protein Content Labeling Claim ( 200 Micrograms or Less ) with 15 Milligrams or Less of Total Particulate per Glove Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: June 14, 2002 Received: June 14, 2002
Dear Mr. Perrella:
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.
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Page 2 - Mr. Perrella
Please be advised that FDA's issuance of a substantial equivalence determination does not 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 Office of Compliance at (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,
Susan Runner
Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental 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 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):* | K021007 |
| Device Name: | Ultra Preserve With Aloe Vera (Green) Natural Rubber Latex Examination Glove Made from Allotex ® an enzyme treated natural rubber latex with a Protein Content Claim of 200 micrograms or less with 15 milligrams or less of Total Particulate per Glove. |
Indications For Use:
The Ultra Preserve With Aloe Vera (Green) 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).
Qim Sahn
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital, Devices 510(k) Number
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH Office of Device Evaluation (ODE)
Prescription Usc OR Over-The-Counter Per 21 CFR 801.109 (Optional Format 1-2-96)
§ 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.