(14 days)
A powder-free patient examination glove is a disposable device made of natural rubber latex material that may bear a trace amount of glove powder and is intended to be worn on the hand or finger(s) for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
A non-sterile, disposable, patient examination glove made of natural rubber latex, powder-free, with or without polymer coating.
The provided document describes the 510(k) summary for the Palm-Pro and Palm-Pro Premium Powder-Free Latex Examination Gloves. These gloves are Class I devices and their acceptance criteria and performance are outlined in relation to established ASTM standards and FDA regulations.
Here's a breakdown of the requested information based on the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Dimensions | ASTM D 3578-01a | Meets (Same as predicate) |
| Physical Properties | ASTM D 3578-01a | Meets (Same as predicate) |
| Freedom from pinholes | ASTM D-3578-01a & FDA 21 CFR 800.20 | Meets (Same as predicate) |
| Powder-Free level | ASTM D 6124-01 | < 2mg/glove (Same as predicate) |
| Protein level | ASTM D-5172-95 | < 50μg/g (Same as predicate) |
| Biocompatibility | Primary Skin Irritation & Dermal Sensitization tests | Not a skin irritation & Not a contact sensitizer (Same as predicate) |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for each of the non-clinical tests (Dimensions, Physical Properties, Freedom from pinholes, Powder-Free, Protein level, Biocompatibility).
Regarding data provenance, the document states: "The performance test data of the non-clinical tests that support a determination of substantial equivalence is the same as mentioned immediately above." This implies that the tests were conducted by the manufacturer, Dipped Products (Thailand) Limited (located in Sri Lanka and Thailand), to demonstrate compliance with the specified ASTM standards and FDA regulations. The nature of these tests (e.g., in-house testing) generally leans towards prospective data collection for product qualification.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable as the device is a Class I medical device (patient examination gloves). The evaluation relies on meeting established engineering and material science standards (ASTM) and regulatory requirements (FDA 21 CFR 800.20), rather than expert interpretation of medical images or diagnostic data. Therefore, there's no "ground truth" derived from medical experts in the context of diagnostic performance.
4. Adjudication method for the test set
This section is not applicable for the same reasons as point 3. Adjudication methods are typically used in studies involving expert interpretation of data where discrepancies need to be resolved. For device performance against engineering standards, the results are typically quantitative measurements against defined thresholds.
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
This section is not applicable. The device is a physical product (gloves) and does not involve AI or human readers for diagnostic interpretation. Therefore, an MRMC study is not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This section is not applicable. The device is a physical product and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device is the defined specifications and thresholds within the ASTM standards and FDA regulations. For example:
- Dimensions: Measured values compared against the ranges specified in ASTM D 3578-01a.
- Physical Properties: Tensile strength, elongation, etc., measured and compared against ASTM D 3578-01a.
- Freedom from pinholes: Testing according to ASTM D-3578-01a and FDA 21 CFR 800.20.
- Powder-Free level: Gravimetric measurement of powder content compared against the < 2mg/glove threshold according to ASTM D 6124-01.
- Protein level: Measured protein content according to ASTM D-5172-95 compared against the < 50μg/g threshold.
- Biocompatibility: Results of standardized primary skin irritation and dermal sensitization tests.
8. The sample size for the training set
This section is not applicable. This is a physical product and does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
This section is not applicable for the same reasons as point 8.
{0}------------------------------------------------
Page 1 of 2
FEB - 7 2005
510(k) Summary
510(k) # K050152
| Manufacturer's Name: | Dipped Products (Thailand) Limited |
|---|---|
| Facility Address: | 400 Deans RoadColombo 10Sri Lanka |
| Telephone number: | +66 74 325329 |
| Facsimile Number: | +66 74 325730 |
| Contact name: | Ian Gordon, VPEmergo Group, Inc.Clearwater, FL 33761 USA727-797-4727 phone727-797-4757 FAX |
| Date of Preparation: | January 14, 2005 |
| Proposed Device: | Palm-Pro and Palm-Pro PremiumPowder-Free Latex Examination Gloves With Protein ContentLabeling Claim (50 Micrograms or Less) |
| Predicate Device: | Kimberly Clark Safeskin product, K012815Ansell Protective Products Accutech Ambi 91-109 productK913766 |
Description of Device:
A non-sterile, disposable, patient examination glove made of natural rubber latex, powder-free, with or without polymer coating.
The proposed and the predicate devices are Class I patient examination gloves, 80L Y Y, powder-frec, that meets all the requirements of ASTM standard D-3578 and FDA 21 CFR 800.20. .
A powder-free patient examination glove is a disposable device Intended Use: made of natural rubber latex material that may bear a trace amount of glove powder and is intended to be worn on the hand or finger(s) for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
| Characteristics | Standards | Device Performance | SE to Predicate |
|---|---|---|---|
| Dimensions | ASTM D 3578-01a | Meets | Same |
| Physical Properties | ASTM D 3578-01a | Meets | Same |
| Freedom from pinholes | ASTM D-3578-01aFDA 21 CFR 800.20 | Meets | Same |
| Powder-Free | ASTM D 6124-01 | < 2mg/glove | Same |
| Protein level | ASTM D-5172-95 | < 50μg/g | Same |
| Biocompatibility | Primary Skin IrritationDermal Sensitization | Not a skin irritationNot a contact sensitizer | Same |
Summary of Technological Characteristics:
{1}------------------------------------------------
Image /page/1/Picture/0 description: The image shows the text "K050162" in a bold, sans-serif font. The text is black against a white background, creating a high contrast. The characters are closely spaced, giving the impression of a single, continuous word or code.
Page 2 of 2 510(k) SUMMARY
Substantial Equivalence - Non-clinical Performance Data.
The performance test data of the non-clinical tests that support a determination of substantial equivalence is the same as mentioned immediately above.
No Clinical Performance Data required.
Conclusion
Based on the non-clinical performance data that demonstrates the proposed device is as safe and as effective, and performs as well as or better than the legally marketed device identified herein, it can be concluded that the proposed Powder-Free Latex Examination Gloves are substantially equivalent to currently marketed devices.
end
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB - 7 2005
Dipped Products (Thailand) Limited C/O Mr. Daniel W. Lehtonen Responsible Third Party Official Intertek Testing Services NA, Incorporated 70 Codman Hill Road Boxborough, Massachusetts 01719
Re: K050152
R030152
Trade/Device Name: Powder Free Latex Patient Examination Gloves 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: January 20, 2005 Received: January 24, 2005
Dear Mr. Lehtonen:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becareermined the device is substantially equivalent (for the relevelect above and nave acterinelosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Interstate conmiseree prior to that have been reclassified in accordance with the provisions of Amendinents, of to dovices that have of the equire approval of a premarket the rederal Pood, Drug, und Ocometive , therefore, market the device, subject to the general approval application (1 Miry) . The general controls provisions of the Act include confors provisions of the Fist - Free Jisting 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 (FMA), it may be subject to back adon't begulations, Title 21, Parts 800 to 898. In your device can be found in the Cours in concerning your device in the Federal Register.
{3}------------------------------------------------
Page 2 - Mr. Lehtonen
Please be advised that FDA's issuance of a substantial equivalence determination does not Flease be auvrsou that 1 Dr. o teemination that your device complies with other requirements Incall that 127 mas made statutes and regulations administered by other Federal agencies. of the Act of ally I ederal statutes and rightenents, including, but not limited to: registration r ou must comply with and and the new (21 CFR Part 801); good manufacturing practice and alla listing (21 CF R Furt 087), labelity systems (QS) regulation (21 CFR Part 820); and if requirenchts as set forth in the quality sign 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) This letter will anow you to begal finding of substantial equivalence of your device to a premiter notification. - The FD Primatis 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), If you desire specific advise to: Joan as (240) 276-0115. 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 inay obtain other general mierers, International and Consumer Assistance at its toll-free Dribber (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Clair Lier, 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
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image is a blank white image. There are a few small, blurry, dark spots scattered throughout the image. The spots are irregularly shaped and do not appear to form any recognizable pattern or object.
Indications for Use
Applicant Name: Dipped Products Limited 510(k) Number (if known):
Device Name:
Common or usual name: powder free latex patient examination gloves with protein content labeling claim (50 micrograms or less)
Trade or Proprietary Name: Model/Catalog Number:
Palm Pro Premium , 6PF1 (6PF1A24E)
Palm Pro Trade or Proprietary Name : 6PF2 (6PF2A24E) Model/Catalog Number:
Indications for Use: A powder-free patient examination glove is a disposable device made of natural rubber latex material that may bear a trace amount of glove powder and is intended to be worn on the hand or linger(s) for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
Over-The-Counter Use X Prescription Use AND/OR ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------(Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Suette Michael and.
Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Dev
510(k) Number: K 030132
§ 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.