(114 days)
A 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. This latex glove contains 50 micrograms or less of total water extractable protein per gram. In addition, this glove has been tested for use with chemotherapy drugs.
Powder Free Examination Gloves are formulated using latex and have colorants. These gloves are offered non-sterile.
The provided text describes the safety and effectiveness of POWDER-FREE LATEX EXAMINATION GLOVES WITH COLORANTS (K020818) by Allegiance Healthcare Corporation. This is a medical device, specifically a patient examination glove, and the document outlines its performance characteristics against established standards.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Implied by standard) | Reported Device Performance |
|---|---|---|
| Primary Skin Irritation | (Implied: No irritation potential) | Glove does not display irritation potential. |
| Guinea Pig Maximization (Sensitization) | (Implied: No sensitization potential) | Glove does not display sensitization potential. |
| Ultimate Elongation & Tensile Strength | Meets or exceeds requirements for rubber examination gloves per ASTM D3578-01. | Glove meets or exceeds requirements for rubber examination gloves per ASTM D3578-01. |
| Barrier Defects | Exceeds requirements per 21 CFR §800.20 and ASTM D3578-01, AQL=2.5. | Glove exceeds requirements per 21 CFR §800.20 and ASTM D3578-01, AQL=2.5. |
| Powder Level | Meets powder level requirements for “Powder Free” designation per ASTM D 3578-01. | Glove meets powder level requirements for “Powder Free” designation per ASTM D 3578-01. |
| Protein Labeling Claim | Meets requirements for protein claim of 50 microgram or less of total water extractable protein per gram. | Glove meets requirements for protein claim of 50 microgram or less of total water extractable protein per gram of glove using the ASTM Lowry test method (ASTM 5712-99). |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for each test. The data provenance is implied to be from internal testing conducted by Allegiance Healthcare Corporation. There is no information provided about the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The tests described are laboratory-based performance tests against established standards (e.g., ASTM, FDA regulations), not tests that require expert interpretation of results to establish ground truth in the way clinical diagnostic devices might.
4. Adjudication method for the test set
This information is not applicable as the tests described are objective, laboratory-based physical and chemical property assessments, not subjective human-interpreted data that would require an adjudication process.
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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices or other AI-assisted diagnostic tools. The gloves are a physical medical device, and their performance is evaluated through standardized laboratory tests. There is no AI component mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical product (gloves) and not an algorithm or AI system.
7. The type of ground truth used
The "ground truth" for the device's performance is established by objective, standardized laboratory test methods and established specifications set by regulatory bodies (e.g., 21 CFR §800.20) and industry standards (e.g., ASTM D3578-01, ASTM 5712-99). These standards define acceptable physical properties, chemical characteristics (like protein levels), and biological safety (skin irritation, sensitization).
8. The sample size for the training set
Not applicable. This device is not an AI system or algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. Since there is no training set, there is no ground truth establishment for one.
{0}------------------------------------------------
K 020818
ງບູນ
Image /page/0/Picture/2 description: The image shows the word "Allegiance" in a stylized font. The word is written in a dark color, possibly black or a dark shade of gray. To the left of the word, there is a symbol that looks like a plus sign or a cross, made up of small squares or dots.
STATEMENT OF SAFETY AND EFFECTIVENESS XIII.
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS POWDER-FREE LATEX EXAMINATION GLOVES WITH COLORANTS
| Manufacturer: | Allegiance Healthcare Corporation1500 Waukegan Road, Bldg. WMMcGaw Park, IllinoisUSA 60085 | |
|---|---|---|
| Regulatory Affairs Contact: | Erica Sethi1500 Waukegan Road, Bldg. WMMcGaw Park, IL 60085 | |
| Telephone: | (847) 785-3337 | |
| Date Summary Prepared: | February 12, 2002 | |
| Common Name: | Patient Examination Glove | |
| Classification: | Glove, Examination (Latex) | |
| Predicate Devices: | Polymer Coated Powder-Free Latex Examination Gloves With Proteinand Chemotherapy Labeling Claim | |
| Description: | Powder Free Examination Gloves are formulated using latex and havecolorants. These gloves are offered non-sterile. | |
| Intended Use: | Powder-Free Latex Examination Gloves are disposable devicesintended for medical purposes that are worn on the examiner's handsor fingers to prevent contamination between patient and examiner.These gloves contain 50 micrograms or less of total water extractableprotein per gram. These gloves have been tested for use withchemotherapy drugs. |
{1}------------------------------------------------
Image /page/1/Picture/0 description: The image shows a sequence of alphanumeric characters, specifically "KO2O818". The characters are written in a handwritten style, with varying stroke thicknesses. The characters are all connected, and the overall appearance is somewhat stylized.
Image /page/1/Picture/1 description: The image shows the word "Allegiance" in a stylized font. The word is written in a dark color, possibly black or a dark shade of gray. To the left of the word, there is a symbol that looks like a plus sign or a cross, also in the same dark color as the word.
STATEMENT OF SAFETY AND EFFECTIVENESS XIII.
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (con't) POWDER-FREE LATEX EXAMINATION GLOVES WITH COLORANTS
| Substantial Equivalence | Powder Free Examination Gloves with colorants are substantially |
|---|---|
| equivalent to Polymer Coated Powder-Free Latex Examination Gloves | |
| in that they provide the following characteristics: | |
| - intended use | |
| - design, product features | |
| - made of natural rubber latex | |
- physical characteristics
Summary of Test Results:
| Test | Result |
|---|---|
| Primary Skin Irritation | Glove does not display irritation potential. |
| Guinea Pig Maximization | Glove does not display sensitization potential. |
| Ultimate Elongation& Tensile Strength | Glove meets or exceeds requirements for rubberexamination gloves per ASTM D3578-01. |
| Barrier Defects | Glove exceeds requirements per 21 CFR§800.20 and ASTM D3578-01, AQL=2.5. |
| Powder Level | Glove meets powder level requirements for “Powder Free”designation per ASTM D 3578-01. |
| Protein Labeling Claim | Glove meets requirements for protein claim of 50 microgram or lessof total water extractable protein per gram of glove using the ASTMLowry test method (ASTM 5712-99). |
{2}------------------------------------------------
Image /page/2/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 three human profiles facing to the right, with flowing lines representing hair or clothing.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 5 2002
Ms. Erica Sethi Manager, Regulatory Affairs Allegiance Healthcare Corporation 1500 Waukegan Road, Building WM McGraw Park, Illinois 60085
Re: K020818
Trade/Device Name: Powder-Free Brown Latex Examination Glove (Tested for Use With Chemotherapy Drugs) with Protein Content Labeling Claim ( 50 Micrograms or Less) Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: April 15, 2002 Received: April 18, 2002
Dear Ms. Sethi:
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.
{3}------------------------------------------------
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.qov/cdrh/dsma/dsmamain.html
Sincerely yours.
Susan Purses
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
{4}------------------------------------------------
Allegiance
Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085-6787 847.473.1500 FAX: 847.785.2460
Page 1 of 1
Applicant: Allegiance Healthcare Corporation
KO20818 510(k) Number:
Powder-Free Brown Latex Examination Glove (Tested For Use With Chemotherapy Drugs) With Protein Content Labeling Claim (50 micrograms or less) Device Name:
Indications For Use: A 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. This latex glove contains 50 micrograms or less of total water extractable protein per gram. In addition, this glove has been tested for use with chemotherapy drugs.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use(Per 21 CFR 801.109) | |
|---|---|
| or | |
| Over-The Counter Use |
| (Division Sign-Off) |
|---|
| Division of Dental, Infection Control,and General Hospital Devices |
510(k) Number .
§ 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.