(78 days)
Powder Free Polymer Coated Patient Examination Gloves are disposable device which is primarily intended for medical purpose worn on the examiner's hands or fingers to prevent contamination between patient and examiner.
Powder Free Polymer Coated Patient Examination Gloves
This document is a 510(k) premarket notification from the FDA, specifically concerning a medical device: Royal Imperial Powder Free Polymer Coated Latex Examination Gloves with Protein Content Labeling Claim (50 Micrograms or Less).
The document does not contain the detailed study information needed to answer your request about acceptance criteria and device performance as if it were a software or AI device. This is a regulatory clearance letter for a physical medical glove. The type of "study" for a glove would involve physical testing and chemical analysis, not the kind of AI/software performance studies you're asking about.
Therefore, I cannot extract the information required for the table and subsequent questions (sample sizes, expert qualifications, MRMC studies, standalone performance, training set data) from this document.
However, I can infer some "acceptance criteria" for this type of device based on general FDA requirements for examination gloves, even though the specific numerical criteria are not in this letter.
Inferred Acceptance Criteria for Examination Gloves (General, Not from this document):
- Protein Content: The claim in the device name "50 Micrograms or Less" is a key acceptance criterion for latex gloves intended to mitigate allergic reactions. This is typically measured through recognized testing standards.
- Physical Integrity/Barrier Protection: This involves testing for pinholes and leaks (e.g., water leak test, air inflation test).
- Tensile Strength and Elongation: To ensure the gloves do not break easily during use.
- Dimensions (Length, Width, Thickness): To ensure proper fit and coverage.
- Biocompatibility: Tests for skin irritation and sensitization.
- Sterility (if claimed): Absence of microorganisms, verified through sterilization validation.
- Powder Residue (if powder-free): A specific limit on residual powder.
Since the provided document is a 510(k) clearance letter, it confirms that the device met the necessary criteria for substantial equivalence to a predicate device, as determined by the FDA. The specific studies and their results would be detailed in the manufacturer's 510(k) submission, which is not this letter.
To directly answer your prompt based only on the provided text, many fields will be "Not Applicable" or "Information Not Provided".
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred for Examination Gloves) | Reported Device Performance (Inferred from 510(k) Clearance) |
|---|---|
| Protein Content (e.g., ≤ 50 µg/g of glove) | Claimed as "50 Micrograms or Less" and accepted by FDA for substantial equivalence. |
| Physical Integrity (e.g., AQL for pinholes) | Met standards for substantial equivalence. |
| Tensile Strength & Elongation | Met standards for substantial equivalence. |
| Dimensions | Met standards for substantial equivalence. |
| Biocompatibility | Met standards for substantial equivalence. |
| Powder Residue (for powder-free claim) | Met standards for substantial equivalence. |
2. Sample sized used for the test set and the data provenance
- Information Not Provided in the document. For physical medical devices like gloves, testing involves batches, and the sample size would depend on the specific ISO or ASTM standards applied (e.g., AQL sampling plans).
- Data Provenance: The manufacturer is Koon Seng Sdn. Bhd. in Muar, Johor, MALAYSIA. The testing would likely have originated in Malaysia or a certified lab approved by the manufacturer. It would be prospective testing of manufactured batches.
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 this device. "Ground truth" in this context refers to physical/chemical properties measured objectively against established standards, not interpretation by human experts in the way AI/software devices are evaluated. The "experts" would be laboratory technicians and engineers performing these tests, and regulatory reviewers from the FDA.
4. Adjudication method for the test set
- Not applicable in the context of this device. Adjudication typically refers to resolving discrepancies in expert interpretations. For physical testing, results are objective measurements. Regulatory review by the FDA (e.g., via a 510(k) process) serves as the "adjudication" or approval of the submission based on the provided data.
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 an examination glove, not an AI or software device that "human readers" would interact with in this manner.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is an examination glove, not an algorithm.
7. The type of ground truth used
- Objective Physical and Chemical Measurements: For gloves, ground truth is established through standardized laboratory tests that measure physical properties (e.g., tensile strength, elongation, dimensions, leak resistance) and chemical properties (e.g., protein content, powder residue, biocompatibility). These are defined by international standards (e.g., ASTM, ISO).
8. The sample size for the training set
- Not applicable. This device is an examination glove and does not involve a "training set" in the machine learning sense. The manufacturing process involves quality control and process validation, which might involve data collection from production runs, but it's not a "training set" for an algorithm.
9. How the ground truth for the training set was established
- Not applicable. As above, no training set for an algorithm.
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Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized design of three wavy lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 3 1 2001
Mr. Lin Weng Heng Factory Manager Koon Seng Sdn. Bhd Batu 4 1/2 Jalan Bakri Muar, Johor MALAYSIA
Re: K012714
Trade/Device Name: Royal Imperial Powder Free Polymer Coated Latex Examination Glove with Protein Content Labeling Claim (50 Micrograms or Less ) Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: October 10, 2001 Received: October 15, 2001
Dear Mr.Heng:
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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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 (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.
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/adma/dsmamain_html
Sincerely yours,
W. AulatonA
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use Statement : Include the following or equivalent for Use page. The 3.0 information, data and labeling claims in the entire the 510(k) submission must support and agree with the Indications for Use statement.
INDICATIONS FOR USE.
| Applicant : | Koon Seng Sdn. Bhd. |
|---|---|
| 510 (k) Number (if known): | K012714 * |
| Device Name: | Powder Free Polymer Coated Patient Examination Gloves |
| Indications For Use: | Powder Free Polymer Coated Patient Examination Gloves are disposable device which is primarily intended for medical purpose worn on the examiner's hands or fingers to prevent contamination between patient and examiner. |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEWILDED )
Concurrence of CDRH Office of Device Evaluation ( ODE)
Olin S. Lin
(Division Sign-Off)
(Continon Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices
510(k) Number 510(k) Number
OR
Prescription Use Per 21 CFR S 01.109
Over - The - counter
(Optional Format 1-2-04)
- For a new submission, do NOT fill in the 510(k) number blank
§ 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.