(93 days)
A powder-free 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
Latex Exam Gloves are formulated using Natural Rubber Latex. The device is offered powder-free and sterile.
This document describes the safety and effectiveness of "Sterile Latex Powder Free Exam Gloves" by Cardinal Health, submitted under 510(k) K081464. The purpose is to demonstrate substantial equivalence to a predicate device (Cardinal Health's Powder-Free Latex Exam Gloves, K024292).
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (from referenced ASTM/CFR/ISO standards) | Reported Device Performance |
|---|---|---|
| Primary Skin Irritation | (Implied: Non-irritating, common biological safety requirement for medical devices in contact with skin) | Gloves are non-irritating. |
| Guinea Pig Maximization | (Implied: No potential for sensitization, common biological safety requirement) | Gloves do not display any potential for sensitization. |
| Ultimate Elongation | Requirements for latex exam rubber gloves per ASTM D 3578 | Gloves meet requirements for latex exam rubber gloves per ASTM D 3578 |
| Tensile Strength | Requirements for latex exam rubber gloves per ASTM D 3578 | Gloves meet requirements for latex exam rubber gloves per ASTM D 3578 |
| Barrier Defects (Permeation) | Requirements per 21 CFR Section 800.20 AQL = 4.0 and ASTM D 3578, AQL = 2.5. Cardinal Health internal AQL is 1.5. | Gloves meet requirements per 21 CFR Section 800.20 AQL = 4.0 and ASTM D 3578, AQL = 2.5. (Implied: And meet Cardinal Health internal AQL = 1.5 as it's a tighter standard) |
| Powder Level | Powder level requirements for "Powder Free" designation using ASTM Standard D 6124 (specifically, below 2 mg of residual powder per glove) | Results generated values below 2 mg of residual powder per glove. |
| Packaging Integrity | Requirements per ANSI, AAMI, ISO 11607-1, Part 1 (Packaging for terminally sterilized medical devices - Part1, requirements for materials, sterile barrier systems and packaging systems) AND ANSI, AAMI, ISO 11607-2, Part 2 (Packaging for terminally sterilized medical devices - part-2) | Packaging was tested (and implicitly meets the requirements) following ANSI, AAMI, ISO 11607-1 Part 1, and ANSI, AAMI, ISO 11607-2 Part 2. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each specific test (e.g., number of gloves tested for elongation, tensile strength, or barrier defects). The data provenance is internal to Cardinal Health, as indicated by "Cardinal Health internal AQL is 1.5" and "Results generated values below 2 mg of residual powder per glove." The tests are likely conducted on product batches as part of quality control and product validation.
- Country of Origin of the Data: Not explicitly stated, but assumed to be from Cardinal Health's manufacturing and testing facilities.
- Retrospective or Prospective: These tests are typically prospective, performed on manufactured products to ensure they meet specifications.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of device (exam gloves) does not typically involve expert "ground truth" establishment in the medical imaging or diagnostic sense. The "ground truth" here is objective, measurable physical and chemical properties and biological safety assessments, measured against established industry standards (ASTM, ISO, CFR). The "experts" would be the personnel performing the laboratory tests (e.g., chemists, materials scientists, microbiologists, toxicologists) who are qualified to conduct these tests according to the specified standards, but their specific number and qualifications are not detailed in this summary.
4. Adjudication Method for the Test Set
Not applicable. The tests are objective and based on established physical, chemical, and biological testing methods. There is no subjective interpretation requiring adjudication among multiple experts. The results are quantitative (e.g., elongation values, tensile strength values, AQL levels, powder weight) or qualitative (e.g., "non-irritating," "no sensitization potential") determined by standardized procedures.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a medical device (exam glove) submission, not an AI/imaging diagnostic device. Therefore, MRMC studies and AI assistance metrics are not relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device (exam glove) submission, not an AI/algorithmic device.
7. The Type of Ground Truth Used
The ground truth used for these tests is based on:
- Established Industry Standards: ASTM D 3578 (for latex exam gloves), ASTM D 6124 (for residual powder), ANSI, AAMI, ISO 11607 Parts 1 & 2 (for packaging integrity). These standards define the acceptable range or threshold for various performance metrics.
- Regulatory Requirements: 21 CFR Section 800.20 (for AQL/barrier defects) and general biological safety principles underlying primary skin irritation and sensitization tests.
- Internal Specifications: Cardinal Health's internal AQL of 1.5, which is a stricter requirement than the regulatory and ASTM standards.
8. The Sample Size for the Training Set
Not applicable. This is a medical device (exam glove) submission, not an AI/learning algorithm. There is no concept of a "training set" in this context.
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no training set for this type of device, this question is not relevant.
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SUMMARY OF SAFETY AND EFFECTIVENESS As required by §807.92(c)
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
Latex Sterile Exam Powder Free Gloves
| Regulatory Affairs Contact: | Steve TamsettCardinal Health1500 Waukegan RoadMcGaw Park, IL 60085 |
|---|---|
| Telephone: | (847) 578.2325 |
| Fax: | (847) 689-2715 |
| Date Summary Prepared: | 8/28/08 |
| Product Trade Name: | Sterile Latex Powder Free Exam Gloves |
| Common Name: | Exam Glove |
| Classification: | Glove, Exam LYY |
| Predicate Devices: | Cardinal Health's Powder-Free Latex ExamGloves (K024292) |
| Description: | Latex Exam Gloves are formulated usingNatural Rubber Latex. The device is offeredpowder-free and sterile. |
Intended Use:
A powder-free 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
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SUMMARY OF SAFETY AND EFFECTIVENESS As required by §807.92(c)
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
| Substantial Equivalence: | Sterile Latex Exam Gloves are substantiallyequivalent to Latex Powder-Free Exam Gloves in thatthey provide the following characteristics:- Same intended use- Same sizes, product features- Both made of Natural Rubber Latex using the samemanufacturing processes |
|---|---|
| -------------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
Summary of Testing:
| Test | Result |
|---|---|
| Primary Skin Irritation | Gloves are non-irritating. |
| Guinea Pig Maximization | Gloves do not display any potential for sensitization. |
| Ultimate Elongation | Gloves meet requirements for latex exam rubbergloves per ASTM D 3578 |
| Tensile Strength | Gloves meet requirements for latex exam rubbergloves per ASTM D 3578 |
| Barrier Defects | Gloves meet requirements per 21 CFR Section800.20 AQL = 4.0 and ASTM D 3578, AQL = 2.5.Cardinal Health internal AQL is 1.5 |
| Data/Test Method | Gloves meet powder level requirements for "Powder Free"designation using ASTM Standard D 6124-Standard testmethod for residual powder on medical gloves. Resultsgenerated values below 2 mg of residual powder per glove. |
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Packaging Integrity:
Packaging was tested following ANSI, AAMI, ISO 11607-1, Part 1, Packaging for terminally sterilized medical devices-Part1, and ANSI, AAMI, ISO 11607-2, Part 2, Packaging for terminally sterilized medical devices-part-2, requirements for materials, sterile barrier systems and packaging systems.
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Public Health Service
AUG 2 8 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Steve Tamsett Regulatory Affairs Manager Cardinal Health 1500 Waukegan Road McGaw Park, Illinois 60085
Re: K081464
Trade/Device Name: Sterile, Latex, Powder-Free Exam Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: August 22, 2008 Received: August 26, 2008
Dear Mr. Tamsett:
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 - Mr. Tamsett
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Clive
Chin Liu, Ph.D.
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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Statement Indications for Use
510(k) Number: (if known): To be Assigned
Device Name: Sterile, Latex, Powder-Free Exam Gloves
Indications For Use:
A powder-free 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
Prescription Use (21 CFR 801 Subpart D) AND/OR
Over-The Counter Use _ x (21 CFR 801 Subpart C)
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(Division Sign-Off)
Concurrence of CDRH, Office of Device Evaluation (ODE)
concurrence
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K081464
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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.