(77 days)
A single use, disposable, powder-free examination glove, intended for medical purposes, that is worn on the examiner's hands to prevent contamination between the patient and examiner.
White colored nitrile, chlorinated, powder-free, ambidextrous patient examination glove that meets all of the requirements of ASTM D 6319-10. Standard Specification for Nitrile Examination Gloves for Medical Application.
The provided document is an FDA 510(k) clearance letter for a "Powder Free Nitrile Patient Examination Glove With Colloidal USP a Skin Protectant Drug." This type of document declares a device substantially equivalent to a predicate device, allowing it to be marketed.
Crucially, this letter does not contain detailed information about acceptance criteria for specific performance metrics, nor does it describe a study proving the device meets particular criteria in the way a clinical trial or a formal performance study report would.
The FDA's 510(k) process primarily relies on demonstrating substantial equivalence to a legally marketed predicate device. This often involves comparing device characteristics (e.g., materials, performance standards) and showing that any differences do not raise new questions of safety or effectiveness.
However, based on the information provided, we can infer some aspects relevant to a hypothetical acceptance criteria and study, particularly regarding the glove's physical performance for medical application:
Inferred Information based on the provided document:
The document states: "Device Description: White colored nitrile, chlorinated, powder-free, ambidextrous patient examination glove that meets all of the requirements of ASTM D 6319-10. Standard Specification for Nitrile Examination Gloves for Medical Application."
This sentence is the key to understanding the "acceptance criteria" and the "study" in this context.
1. A table of acceptance criteria and the reported device performance
Since the document explicitly states the device "meets all of the requirements of ASTM D 6319-10," the acceptance criteria are those defined in that ASTM standard. Without access to ASTM D 6319-10, we cannot provide the full table, but common criteria for examination gloves include:
| Acceptance Criteria (Based on ASTM D 6319-10 requirements) | Reported Device Performance |
|---|---|
| Freedom from holes (AQL) | Meets ASTM D 6319-10 requirements |
| Physical dimensions (length, palm width, thickness) | Meets ASTM D 6319-10 requirements |
| Tensile strength (before and after aging) | Meets ASTM D 6319-10 requirements |
| Elongation at break (before and after aging) | Meets ASTM D 6319-10 requirements |
| Powder residue (if applicable, though this is "powder-free") | Meets ASTM D 6319-10 requirements |
| Protein content (for latex gloves, not directly applicable here but part of general glove standards) | Not applicable (Nitrile) |
Note: The exact numerical values for these criteria would be detailed within the ASTM D 6319-10 standard. The device "meets" these, implying the test results fell within the acceptable ranges specified by the standard.
2. Sample size used for the test set and the data provenance
The document does not specify the sample size for testing against ASTM D 6319-10. ASTM standards typically define sampling plans (e.g., AQL levels for defect testing).
- Data provenance: Not specified, but generally, manufacturers perform these tests at their own facilities or accredited labs. It would be a prospective test conducted on representative samples of the manufactured gloves. Country of origin for the data is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable in this context. For physical performance tests of examination gloves, ground truth is established by objective measurements based on the ASTM standard's methodology. There are no "experts" in the sense of clinicians or radiologists establishing a diagnostic ground truth. Lab technicians trained in material testing and quality control would perform the tests.
4. Adjudication method for the test set
Not applicable. The tests are objective measurements, not subjective evaluations requiring adjudication.
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 clearance for an examination glove, not an AI or diagnostic imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used
For the physical performance aspects (freedom from holes, dimensions, tensile strength, elongation), the "ground truth" is derived from objective measurements of the manufactured gloves against the scientifically established and consensus-driven parameters defined in the ASTM D 6319-10 standard.
8. The sample size for the training set
Not applicable. There is no AI model or training set involved for this type of device. Manufacturing processes are optimized, but this isn't "training" in the machine learning sense.
9. How the ground truth for the training set was established
Not applicable, as there is no training set in the AI sense.
Summary of what is specifically addressed in the document:
- The device is a "Powder Free Nitrile Patient Examination Glove With Colloidal USP a Skin Protectant Drug."
- It is classified as Class I, product code LZA (Patient Examination Glove).
- It is intended for "medical purposes, that is worn on the examiner's hands to prevent contamination between the patient and examiner."
- It is for over-the-counter use (not prescription).
- The primary means of demonstrating performance for physical characteristics is adherence to ASTM D 6319-10. Standard Specification for Nitrile Examination Gloves for Medical Application.
The FDA's decision of substantial equivalence is based on the manufacturer's demonstration that this device meets these established performance standards and is similar in intended use and technological characteristics to a predicate device. The letter itself doesn't contain the raw data or detailed study reports, but rather the regulatory conclusion based on the submission which would have included such data.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Joseph H. Neuser President Derma Care Plus Products, LLC 2614 Main Street Green Bay, Wisconsin 54311
AUG 2 3 2011
Re: K111589
Trade/Device Name: Powder Free Nitrile Patient Examination Glove With Colloidal USP a Skin Protectant Drug Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: August 3, 2011 Received: August 8, 2011
Dear Mr. Neuser:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Neuser
Enclosure
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803). please go to http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Anthony D. Watson
Anthony D. Watson, B.S., M.S., M.B.A.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devi Office of Device Evaluation Center of Devices and Radiological Health
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K///589
INDICATIONS FOR USE STATEMENT
Applicant: DERMA CARE PLUS PRODUCTS, LLC
Device Name: Powder free Nitrile patient examination glove with colloidal oatmeal USP a skin protectant drug
Classification Name: Glove, Patient Examination, Poly - 80 LZA
Device Description: White colored nitrile, chlorinated, powder-free, ambidextrous patient examination glove that meets all of the requirements of ASTM D 6319-10. Standard Specification for Nitrile Examination Gloves for Medical Application.
Indications For Use: A single use, disposable, powder-free examination glove, intended for medical purposes, that is worn on the examiner's hands to prevent contamination between the patient and examiner.
Prescription Use: NO
and /or Over-The-Counter Use: YES
(21 CFR 801 Subpart C)
Eldrett F. Clemens-Williams
(Division Sign Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: KI|1589
§ 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.