(41 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.
Powder-free, Latex Patient Examination Glove with protein content labelling claim (50 ug/g glove or less).
This document is a 510(k) clearance letter from the FDA for a medical device, specifically a "Powder-Free, Latex Patient Examination Glove with protein content labelling claim (50 ug/g glove or less)."
The letter indicates that the device has been reviewed and found to be "substantially equivalent" to legally marketed predicate devices. This type of regulatory clearance does not necessarily involve a clinical study to prove performance against specific acceptance criteria in the way that a novel device might. Instead, it relies on demonstrating that the new device is as safe and effective as a device already on the market.
Therefore, for this specific submission:
- There is no explicit table of acceptance criteria and reported device performance as would be found for a new diagnostic or therapeutic device. The "acceptance criteria" here are essentially the requirements for demonstrating substantial equivalence to a predicate device, which would include performance benchmarks for characteristics like barrier integrity, tensile strength, and protein content. The "reported device performance" would be the results of the tests conducted by Kossan Latex Industries (M) Sdn. Bhd. to show that their glove meets these benchmarks. However, these specific test results are not detailed in the provided FDA letter.
- The document does not detail a specific "study" in the clinical trial sense for an AI device. The 510(k) process for a glove primarily focuses on performance testing (e.g., integrity and strength tests, protein content assays) against relevant standards and the predicate device.
Given the nature of a 510(k) for a patient examination glove, many of the requested fields are not applicable or the information is not present in the provided FDA clearance letter.
Here's how to address your request based on the provided document and general understanding of 510(k) approvals for such devices:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied for Latex Gloves) | Reported Device Performance (Not explicitly detailed in FDA letter, but assumed to meet criteria for clearance) |
|---|---|
| Protein Content: ≤ 50 micrograms/gram of glove | "with protein content labelling claim (50 ug/g glove or less)" - Device is designed to meet this claim. |
| Barrier Integrity (e.g., AQL for pinholes): Typically 1.5 - 4.0 | Assumed to meet relevant ASTM or ISO standards for medical gloves. |
| Physical Properties (e.g., Tensile Strength, Elongation): As per standard specifications | Assumed to meet relevant ASTM or ISO standards for medical gloves. |
| Biocompatibility: Non-toxic, non-irritating, non-sensitizing | Assumed to meet relevant ISO or FDA biocompatibility guidelines. |
| Sterility (if applicable): Sterile (if claimed) | Not claimed as sterile in this document. |
| Powder-Free: Must meet powder-free requirements | "Powder-Free" - Device is designed to meet this claim. |
Note: The FDA letter confirms the device is "substantially equivalent" to legally marketed predicate devices, which implicitly means it meets industry standards and performance benchmarks for patient examination gloves. The specific test results are part of the detailed 510(k) submission, not typically included in the public clearance letter.
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in the provided FDA letter. For physical and chemical tests of gloves, sample sizes are typically determined by relevant ISO or ASTM standards (e.g., ISO 2859-1 for AQL sampling, ISO 37 for tensile properties).
- Data Provenance: Not specified, but the applicant is Kossan Latex Industries (M) Sdn. Bhd. from Malaysia. Testing would have been conducted by the manufacturer or a contracted lab. The data would be prospective, as it involves testing of the device for regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable in the context of device performance testing for gloves. "Ground truth" in this context refers to standardized measurements (e.g., protein content via validated assays, physical properties via test machines). Clinical expert review is not generally used to establish performance for these types of physical/chemical properties.
4. Adjudication method for the test set
- Not applicable. Performance tests for gloves are typically objective measurements with predefined pass/fail criteria based on standards. There is no expert adjudication process for these types of tests.
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 device is a patient examination glove, not an AI-assisted diagnostic or imaging system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a patient examination glove, not an algorithm.
7. The type of ground truth used
- Objective Measurements/Standardized Assays: The "ground truth" for glove performance involves objective measurements of physical properties (tensile strength, elongation, barrier integrity via water leak tests) and chemical properties (extractable protein content via validated assays like modified Lowry or ELISA). Compliance with relevant ASTM or ISO standards serves as the benchmark.
8. The sample size for the training set
- Not applicable. This is not a machine learning/AI device, so there is no "training set."
9. How the ground truth for the training set was established
- Not applicable. As above, no training set is involved.
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three lines representing its body and wings. The eagle faces right and is positioned within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 3 1998
Mr. Bob Chan General Manager Kossan Latex Industries (M) Sdn. Bhd. Lot 16632, 5¼ Miles, Jalan Meru, 41050 Klang Selangor Darul Ehsan, MALAYSIA
K984019 Re : Powder-Free, Latex Patient Examination Glove Trade Name: with Protein Content Labeling Claim (50 micrograms or less) Regulatory Class: I Product Code: LYY Dated: November 7, 1998 November 12, 1998 Received:
Dear Mr. Chan:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਉ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
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Page 2 - Mr. Chan:
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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 Other qeneral premarket notification" (21CFR 807.97). information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address
"http://www.fda.gov/cdrh/dsma/dsmamajn.html".
Sincerely yours
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section 3
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510 (K) Number (if known) : K984019
Device Name
: Powder-free, Latex Patient Examination Glove with protein content labelling claim (50 ug/g glove or less).
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use ( Per 21 CFR 801. 109 ) OR
AV
Over-The-Counter Use
( Optional Format 1-2-96 )
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices
Chin
510(k) Number .
arry W
§ 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.