(16 days)
Not Found
Not Found
No
The 510(k) summary describes a standard examination glove and contains no mention of AI or ML technology.
No.
The device is described as a glove intended to prevent contamination between the patient and examiner, not to treat a medical condition.
No
Explanation: The device is a patient examination glove, described as a barrier to prevent contamination, not for diagnosing medical conditions.
No
The device is a physical examination glove, which is a hardware medical device, not software.
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 examiner's hand or finger to prevent contamination between patient and examiner." This describes a physical barrier device used during a medical examination.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. This glove does not perform any such test.
- Lack of IVD Characteristics: The description and testing information provided do not mention any analysis of biological samples, chemical reactions, or diagnostic procedures. The testing focuses on physical properties and biocompatibility (skin irritation, tensile strength, barrier defects).
Therefore, the device described is a medical device, specifically a Class I or Class II medical device (depending on the specific regulations and risk classification), but it is not an IVD.
N/A
Intended Use / Indications for Use
These examination gloves are disposable devices intended for medical purposes that are worn on the examiner's hands or fingers to prevent contamination between patient and examiner.
Product codes
80 LZA
Device Description
Nitrile Powder-Free Examination Gloves are formulated using nitrile and offered powder-free.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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
Not Found
Summary of Performance Studies
| Test | Result |
|---|---|
| Primary Skin Irritation | Gloves show no irritation. |
| Guinea Pig Maximization | Gloves do not display any potential for irritation. |
| Tensile Strength | Gloves meet or exceed requirements per ASTM D6319-00a. |
| Barrier Defects | Gloves meet or exceed requirements per 21 CFR§800.20 and ASTM D6319-00a. |
Key Metrics
Not Found
Predicate Device(s)
Flexam Nitrile T Ambi Examination Gloves
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
XIII. SUMMARY OF SAFETY AND EFFECTIVENESS
Allegiance
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS NITRILE POWDER-FREE EXAMINATION GLOVES
Applicant/Sponsor: Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, IL 60085
Regulatory Affairs Contact: Erica Sethi Allegiance Healthcare Corporation 1500 Waukegan Road, Bldg. WM McGaw Park, IL 60085
Telephone: (847) 785-3337
Date Summary Prepared: September 10, 2002
Product Trade Name: Undetermined
Common Name: Examination Glove
Classification: Patient Examination Glove
Predicate Devices: Flexam Nitrile T Ambi Examination Gloves, Allegiance Healthcare Corp.
Description: Nitrile Powder-Free Examination Gloves are formulated using nitrile and offered powder-free.
Intended Use: These examination gloves are disposable devices intended for medical purposes that are worn on the examiner's hands or fingers to prevent contamination between patient and examiner.
1
Substantial Equivalence: Nitrile Powder-Free Examination Gloves are substantially equivalent to Allegiance Healthcare's Flexam Nitrile T Ambi Examination Gloves in that they provide the following characteristics:
- same indication for use
- same sizes
- both made of nitrile
- both offered beaded and powder-free
Summary of Testing:
| Test | Result |
|---|---|
| Primary Skin Irritation | Gloves show no irritation. |
| Guinea Pig Maximization | Gloves do not display any potential for irritation. |
| Tensile Strength | Gloves meet or exceed requirements per ASTM D6319-00a. |
| Barrier Defects | Gloves meet or exceed requirements per 21 CFR§800.20 |
| and ASTM D6319-00a. |
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of three stylized human profiles facing to the right, with three lines above them that resemble a bird in flight.
Public Health Service
OCT 0 9 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Erica Sethi Manager, Regulatory Affairs Allegiance Healthcare Corporation 1500 Waukegan Road, Building WM McGaw Park, Illinois 60085
Re: K023170
Trade/Device Name: Nitrile Powder-Free Examination Gloves Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: 80 LZA Dated: September 10, 2002 Received: September 23, 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.
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 (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,
Timothy A. Ulatowski
Timothy 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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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: | K023170 |
| Device Name: | Undetermined Nitrile Powder-Free Examination Gloves |
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.
(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
Les. Victorh
(Division Sign-Off) Division of Anesthestology, General Hospital, Infection Control, Dental Device
510(k) Number: