(76 days)
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Not Found
No
The device is a standard examination glove and the summary contains no mention of AI or ML capabilities.
No
The device is a patient examination glove, which is intended to prevent contamination between the patient and examiner, not to treat or cure a disease or condition.
No.
The device is a patient examination glove, intended to prevent contamination between the patient and examiner, not to diagnose a medical condition.
No
The device description clearly states the device is a physical glove made of latex with a polymer coating, intended to be worn on the hand. It undergoes physical and chemical testing, not software validation.
Based on the provided information, 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. This is a barrier device for physical protection.
- Device Description: The description confirms it's a glove made of latex with a polymer coating.
- Performance Studies: The performance studies focus on the physical properties of the glove (irritation, sensitization, strength, barrier defects, powder level, protein level) and its resistance to chemotherapy drugs. These are all related to the glove's function as a physical barrier and protective device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information for diagnosis, monitoring, or treatment. IVDs typically involve reagents, instruments, or software used to analyze biological samples like blood, urine, or tissue.
Therefore, this device falls under the category of a medical device, specifically a patient examination glove, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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
LYY
Device Description
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
hands or fingers
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner
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
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Summary of Performance Studies
Glove does not display irritation potential.
Glove does not display sensitization potential.
Glove meets or exceeds requirements for rubber examination gloves per ASTM D3578-00.
Glove meets or exceeds requirements per 21 CFR §800.20 and ASTM D3578-00, AQL=2.5.
Glove meets powder level requirements for "Powder Free" designation per ASTM D 3578-00.
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).
Key Metrics
Not Found
Predicate Device(s)
Positive Touch Powder-Free Latex Examination Gloves With Protein and Chemotherapy Labeling Claim
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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
SEP 2 4 2001
Image /page/0/Picture/1 description: The image shows the word "Allegiance" in a stylized font. The word is written in black and appears to be slightly italicized. There is a symbol to the left of the word that looks like a plus sign made up of small circles.
STATEMENT OF SAFETY AND EFFECTIVENESS XIII.
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN & CHEMOTHERAPY LABELING CLAIM
Manufacturer:
Allegiance Healthcare Sdn. Bhd. Plot 87 Kampung Jawa Bayan Lepas Penang, West Malaysia 11900
Regulatory Affairs Contact:
Erica Sethi 1500 Waukegan Road, Bldg. WM McGaw Park, IL 60085
Telephone:
(847) 785-3337
June 21, 2001
Date Summary Prepared:
Common Name:
Classification:
Predicate Devices:
Description:
Intended Use:
Patient Examination Glove
Glove, Examination (Latex)
Positive Touch Powder-Free Latex Examination Gloves With Protein and Chemotherapy Labeling Claim
10/214
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.
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 contains the word "Allegiance" in a stylized font. To the left of the word is a symbol that resembles a plus sign made up of small squares. The word "Allegiance" is written in a dark color, possibly black or a dark shade of gray. The font appears to be bold and slightly italicized.
STATEMENT OF SAFETY AND EFFECTIVENESS XIII.
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (con't) POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN AND CHEMOTHERAPY LABELING CLAIM
Substantial Equivalence
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
Glove does not display irritation potential.
Glove does not display sensitization potential. Guinea Pig Maximization
Ultimate Elongation & Tensile Strength
Primary Skin Irritation
Barrier Defects
Powder Level
Protein Labeling Claim
Glove meets or exceeds requirements for rubber examination gloves per ASTM D3578-00.
Glove meets or exceeds requirements per 21 CFR $800.20 and ASTM D3578-00, AQL=2.5.
Glove meets powder level requirements for "Powder Free" designation per ASTM D 3578-00.
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 shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 4 2001
Ms. Erica Sethi Manager of Regulatory Affairs Allegiance Healthcare Corporation 1500 Waukegan Road, Building WM McGaw Park, Illinois 60085
Re: K012149
Trade/Device Name: Powder-Free Latex Examination Gloves with Protein, Chemotherapy Labeling Claim Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: June 21, 2001 Received: July 10, 2001
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.
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.
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Page 2 - Ms. Sethi
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 (section 531-542 of the Act; 21); CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your 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 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 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.
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/4/Picture/0 description: The image shows the word "Allegiance" in a bold, italicized font. To the left of the word is a symbol that resembles a plus sign, but it is made up of many small dots. The word is in black, and the background is white.
Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085-6787 847.473.1500 FAX: 847.785.2460
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| Applicant: | Allegiance Healthcare Corporation |
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| 510(k) Number: | K012149 |
| Device Name: | 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 __________
| (Per 21 CFR 801.109) | or | Over-The Counter Use __________ |
|---|---|---|
| ----------------------------------------------------- | ---- | --------------------------------- |
(Division Sign-Off) (Division Sign-Un)
Division of Dental, Infection Control,
Division of Dental, Devices Division of Dollars and General Hospital V 015 510(k) Number ------