(16 days)
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No
The device description and performance studies focus on the physical properties and barrier function of examination gloves, with no mention of AI or ML technologies.
No
The device, a patient examination glove, is intended for medical purposes to prevent contamination between patient and examiner, not to treat or cure a disease or condition.
No
Explanation: The device is a patient examination glove used to prevent contamination between patient and examiner. Its function is protective, not diagnostic.
No
The device is a physical examination glove made of latex, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is a "patient examination glove" worn on the hand or finger to prevent contamination between patient and examiner. This is a physical barrier device used during patient examination.
- Device Description: The description confirms it's a latex glove with a polymer coating, designed to be worn on the hand.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This glove does not perform any such analysis or testing of biological samples.
- Performance Studies: The performance studies focus on the physical properties of the glove (irritation, sensitization, strength, barrier defects, powder level, protein level) and its ability to act as a barrier, not on any diagnostic capabilities.
The fact that it's tested for use with chemotherapy drugs and has a protein labeling claim relates to its barrier properties and potential for allergic reactions, not to any diagnostic function.
N/A
Intended Use / Indications for Use
Positive Touch Powder-Free Latex Examination Gloves With Protein and Chemotherapy Labeling Claim are disposable devices intended for medical purposes that are worn on the examiner's hands or fingers to prevent contamination between patient and examiner. These gloves have been tested for use with chemotherapy drugs using ASTM F 739-99a.
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.
Product codes (comma separated list FDA assigned to the subject device)
LYY
Device Description
Positive Touch Powder Free Examination Gloves With Protein and Chemotherapy Labeling Claim are formulated using latex and are coated with a Polymer coating. These gloves are offered non-sterile in sizes X-small, Small, Medium, Large and X-large.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
Positive Touch Powder-Free Latex Examination Gloves With Protein and Chemotherapy Labeling Claim
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.
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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).
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§ 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.
0
Ko24292
Image /page/0/Picture/2 description: The image shows the word "Allegiance" in a bold, stylized font. To the left of the word is a symbol resembling a plus sign, but it is made up of many small squares. The word "Allegiance" is written in all lowercase letters, and the letters are connected to each other.
STATEMENT OF SAFETY AND EFFECTIVENESS XIII.
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS POSITIVE TOUCH POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN & CHEMOTHERAPY LABELING CLAIM
| Manufacturer: | Allegiance Healthcare Corporation
1500 Waukegan Road
McGaw Park, Illinois USA |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory Affairs Contact: | Erica Sethi
1500 Waukegan Road, Bldg. WM
McGaw Park, IL 60085 |
| Telephone: | (847) 785-3337 |
| Date Summary Prepared: | 11/20/02 |
| Common Name: | Patient Examination Glove |
| Classification: | Glove, Examination (Latex) |
| Predicate Devices: | Positive Touch Powder-Free Latex Examination Gloves With Protein
and Chemotherapy Labeling Claim |
| Description: | Positive Touch Powder Free Examination Gloves With Protein and
Chemotherapy Labeling Claim are formulated using latex and are coated
with a Polymer coating. These gloves are offered non-sterile in sizes X-
small, Small, Medium, Large and X-large. |
| Intended Use: | Positive Touch Powder-Free Latex Examination Gloves With Protein and
Chemotherapy Labeling Claim are disposable devices intended for
medical purposes that are worn on the examiner's hands or fingers to
prevent contamination between patient and examiner. These gloves have
been tested for use with chemotherapy drugs using ASTM F 739-99a. |
1
Image /page/1/Picture/0 description: The image shows the word "Allegiance" in a bold, stylized font. To the left of the word is a symbol resembling a plus sign, but it is made up of many small dots. The text is in black and the background is white.
STATEMENT OF SAFETY AND EFFECTIVENESS XIII.
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (con't) POSITIVE TOUCH POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN AND CHEMOTHERAPY LABELING CLAIM
| Substantial Equivalence | Positive Touch Powder Free Examination Gloves With Protein and
Chemotherapy Labeling Claim are substantially equivalent to Positive
Touch Powder-Free Latex Examination Gloves in that they provide the
following characteristics: |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | - intended use |
| | - size, 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 rubber |
| examination gloves per ASTM D3578-01. | |
| Barrier Defects | Glove meets or 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 less |
| of total water extractable protein per gram of glove using the ASTM | |
| Lowry test method (ASTM 5712-95). |
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's symbol, which is a stylized representation of a human figure. The symbol is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 0 9 2003
Ms. Erica Sethi Manager, Regulatory Affairs Allegiance Healthcare Corporation 1500 Waukegan Road, Building WM McGaw Park, Illinois 60085
Re: K024292
Trade/Device Name: Positive Touch Powder-Free Latex Examination Gloves Contains 50 Micrograms or Less of Total Extractable Protein Per Gram and Chemotherapy Claim Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: November 20, 2002 Received: December 24, 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.
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Page 2 - Ms. Sethi
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 vour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). 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) you may obtain. 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 vour Timothy
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
4
K024 292
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 |
|---|---|
| 510(k) Number: | K024292 |
| Device Name: | Positive Touch Powder-Free Latex Examination Gloves With Protein, |
| Chemotherapy Labeling Claim | |
| 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 Over-The Counter Use or (Per 21 CFR 801.109) (Division Sign-Off) Hospital. Division of Anesthesiolog Infection Control, D