(52 days)
No K/DEN number is provided in the text for the Predicate Device(s).
Not Found
No
The summary describes a standard examination glove and does not mention any AI or ML capabilities.
No
The device, examination gloves, is for preventing contamination and protecting the wearer, not for treating a disease or condition.
No
Explanation: The document describes examination gloves, which are used to prevent contamination and protect the wearer, not to diagnose a medical condition. Their performance studies focus on irritation, tensile strength, and barrier defects, not diagnostic efficacy.
No
The device is a physical medical device (examination gloves) and does not involve any software component.
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 and protect against chemotherapy drugs. This is a barrier device for physical protection.
- IVD Definition: In vitro diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Lack of Diagnostic Function: The description and testing summary do not mention any analysis of biological specimens or providing diagnostic information. The testing focuses on physical properties (tensile strength, barrier defects) and biological compatibility (skin irritation).
Therefore, the device's function and intended use fall outside the scope of an In Vitro Diagnostic.
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. In addition, these gloves are worn to protect the wearer against exposure to chemotherapy drugs.
Product codes (comma separated list FDA assigned to the subject device)
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
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
| 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 (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Flexam Nitrile T Ambi Examination Gloves, Allegiance Healthcare Corp.
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.
Not Found
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).
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
1222
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: August 9, 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. In addition, these gloves are worn to protect the wearer against exposure to chemotherapy drugs.
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 intended use
- same sizes
- both made of nitrile
- both offered beaded and powder-free
- both worn to protect the wearer against exposure to chemotherapy drugs
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized design of three abstract human figures, possibly representing a family or community.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 11 2002
Ms. Erica Sethi Quality & Regulatory Affairs Allegiance Healthcare Corporation 1500 Waukegan Road McGraw Park, Illinois 60085
Re: K022765
Trade/Device Name: Powder-Free Blue Nitrile Examination Gloves with Tested For Use with Chemotherapy Drugs Labeling Claim Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: 80 LZA Dated: September 4, 2002 Received: September 6, 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.
3
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.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Palaciu Coccinitffe
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
cGaw Park, Illinois 60085-6 FAX: 847 785 7
Page 1 of 1
Allegiance Healthcare Corporation Applicant:
KO22765 510(k) Number:
Undetermined Powder-Free Blue Nitrile Examination Device Name: Glove with Tested For use with Citem THERAPY DRUGS 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. In addition, these gloves are worn to protect the wearer against exposure to 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
Qiu S. Lin
n of Anesthesiology, General Hospital, n Control, Dental De
510(k) Number: K022765