(97 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. In addition, these gloves are worn to protect the wearer against exposure to chemotherapy drugs.
Nitrile Powder-Free Examination Gloves with coating are formulated using nitrile and offered powder-free.
This document describes the safety and effectiveness summary for Cardinal Health's Nitrile Powder-Free Examination Gloves with Coating, submitted under 510(k) number K032444.
1. Table of Acceptance Criteria and Reported Device Performance:
The acceptance criteria for this device are based on meeting safety and performance standards for examination gloves, particularly with added protection against chemotherapy drugs. The reported performance demonstrates compliance with these standards.
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Primary Skin Irritation | Absence of irritation | Gloves show no irritation. |
| Guinea Pig Maximization | No potential for irritation/sensitization | Gloves do not display any potential for irritation. |
| Tensile Strength | Meets or exceeds requirements per ASTM D6319-00a3 | Gloves meet or exceed requirements per ASTM D6319-00a3. |
| Barrier Defects | Meets or exceeds requirements per 21 CFR §800.20 and ASTM D6319-00a63 | Gloves meet or exceed requirements per 21 CFR §800.20 and ASTM D6319-00a63. |
| Chemotherapy Testing | Tested for chemotherapy drugs using ASTM F739-99a (Implied: demonstrates resistance/protection) | Tested for chemotherapy drugs using ASTM F739-99a. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the exact sample sizes used for each of the tests (e.g., number of gloves tested for tensile strength or barrier defects, number of animals for skin irritation). The data provenance is not explicitly stated as country of origin, but it is implied to be from Cardinal Health's testing procedures, conducted prior to the 510(k) submission date of July 25, 2003, hence, retrospective in relation to the submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the summary. The tests performed are standardized material and biological safety tests (ASTM, CFR), which rely on established protocols rather than expert consensus on individual cases.
4. Adjudication Method for the Test Set:
This is not applicable for the types of tests described. The tests are based on objective measurements and established pass/fail criteria from regulatory standards and ASTM methods, not on expert adjudication of interpretations.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. The device is an examination glove, and the testing focuses on its material properties, barrier integrity, and biological safety, not on diagnostic accuracy requiring human reader interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This is not applicable. The device is a physical product (a glove), not an algorithm or AI software. Therefore, there is no concept of "standalone performance" in the context of an algorithm.
7. The Type of Ground Truth Used:
The ground truth used for these tests is based on:
- Established ASTM Standards: For mechanical properties like tensile strength and barrier integrity.
- Regulatory Requirements: As stipulated by 21 CFR for barrier defects.
- Biological Safety Protocols: For primary skin irritation and guinea pig maximization, which determine the absence of irritation or sensitization.
- Standardized Chemotherapy Drug Permeation Testing: Using ASTM F739-99a.
8. The Sample Size for the Training Set:
This is not applicable. The device is a physical product, not an AI/ML algorithm that requires a training set. The manufacturing process itself is expected to produce consistent products that adhere to the established quality and performance standards.
9. How the Ground Truth for the Training Set Was Established:
This is not applicable as there is no "training set" in the context of developing this medical device. The "ground truth" for ensuring quality during manufacturing would be established through ongoing quality control processes that verify the product meets the specifications outlined by the ASTM and CFR standards, as detailed in point 7.
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NOV 1 3 2003
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XIII. SUMMARY OF SAFETY AND EFFECTIVENESS
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS LOT OF STOP TH COATING, BLUE NITRILE POWDER-FREE EXAMINA TION GLC WIFF for
Applicant/Sponsor: Cardinal Health 1500 Waukegan Road McGaw Park, IL 60085
Regulatory Affairs Contact: Erica Sethi Cardinal Health 1500 Waukegan Road, Bldg. WM McGaw Park, IL 60085
Telephone: (847) 785-3337
Date Summary Prepared: 7/25/03
Product Trade Name: Undetermined
Common Name: Examination Glove
Classification: Patient Examination Glove
Predicate Devices: Nitrile Powder-Free Examination Gloves, Cardinal Health,
Description: Nitrile Powder-Free Examination Gloves with coating 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.
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Substantial Equivalence: Nitrile Powder-Free Examination Gloves with Coating are substantially equivalent to Cardinal Health's Nitrile Powder-Free 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 D6319-00a3. |
| Barrier Defects | Gloves meet or exceed requirements per 21 CFR§800.20and ASTM D6319-00a63. |
| Chemotherapy testing | Tested for chemotherapy drugs using ASTM F739-99a |
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Public Health Service
NOV 1 3 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Cardinal Health C/O Ms. Erica Sethi Manager, Regulatory Affairs Medial Product and Services 1500 Waukegan Road Bldg WM Mcgaw Park, Illinois 60085
Re: K032444
Trade/Device Name: Nitrile Powdered- Free Examination Glove with Lotion Coating And use for Chemotherapy Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZC Dated: October 23, 2003 Received: October 30, 2003
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 your 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. 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 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,
QurLs
Chiu Lin, Ph.D. 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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1500 Waukegan Road McGaw Park, Illinois 60085-6787 847.473.1500 FAX: 847.785.2460
Susanna F. Basuld
Anesthesiology, General Hospital, on Control, Dental Devices
510(k) Number: K032444
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Applicant:
Cardinal Health
<032444
510(k) Number:
Device Name: Undetermined
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.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) or
Over-The Counter Use
§ 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.