The surgical glove is a device made of synthetic latex intended to be worn by surgeons and/or operating room personnel to protect a surgical wound from contamination.

Device Description

The Powder Free Polymer Coated Green Neoprene Surgical Gloves, Sterile are made of synthetic rubber latex intended to be worn on the hand of healthcare personnel, operating room personnel and similar personnel to prevent contamination between the healthcare or similar personnel and the patient's body, fluids, waste, or environment.

AI/ML Overview

The provided text is a 510(k) summary for a medical device, specifically Powder Free Polymer Coated Green Neoprene Surgical Gloves, Sterile. This type of document is for regulatory clearance of medical devices, demonstrating substantial equivalence to a predicate device, rather than a clinical study report proving diagnostic performance of an AI algorithm.

Therefore, many of the requested categories for AI algorithm studies (such as sample size for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) are not applicable to this document.

However, I can extract the acceptance criteria and the "study" (which in this context refers to the testing performed to demonstrate compliance with standards) that proves the device meets them.

Here's the information derived from the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

CHARACTERISTICS	STANDARDS / Acceptance Criteria	DEVICE PERFORMANCE
Dimensions	ASTM D 3577 - 01aE2	Meets
Physical Properties	ASTM D 3577 - 01aE2	Meets
Freedom from pinholes	ASTM D 3577 - 01aE2; FDA 21 CFR 800.20 (Pinhole AQL)	Meets
Powder Residual	ASTM D 6124 - 01	Meets (< 2 mg/glove)

2. Sample size used for the test set and the data provenance

Sample Size: Not specified in the document. Testing would typically involve a statistically relevant sample size as per the ASTM standards referenced.
Data Provenance: The manufacturing company is WRP Asia Pacific Sdn Bhd, located in Sepang, Selangor Darul Ehsan, Malaysia. The testing would have been conducted by or for this company. The document does not specify if the data is retrospective or prospective, but testing for device compliance is generally prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not Applicable. This is a physical device testing, not an AI diagnostic study that relies on expert interpretation for ground truth. Compliance is determined by adherence to established material and performance standards.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not Applicable. This refers to expert review in diagnostic AI studies. Device testing for surgical gloves follows specific methods outlined in the ASTM standards, which do not involve expert adjudication in this manner.

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 not an AI diagnostic system.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not Applicable. This is not an AI algorithm. The device's performance is standalone in the sense that its physical properties are measured directly against standards.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device is defined by the established specifications and test methods within the referenced ASTM standards (e.g., ASTM D 3577 - 01aE2 for dimensions, physical properties, and freedom from pinholes; ASTM D 6124 - 01 for powder residual; and FDA 21 CFR 800.20 for pinhole AQL). These standards provide objective, measurable criteria for device performance.

8. The sample size for the training set

Not Applicable. This is not an AI model requiring a training set.

9. How the ground truth for the training set was established

Not Applicable. This is not an AI model.

Summary

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Image /page/0/Picture/0 description: The image shows a logo with the letters "WRP" in bold, white font against a black, hexagonal background. The letters are large and take up most of the space within the hexagon. The logo is simple and eye-catching, with a clear contrast between the text and the background.

K024130

SPECIAL 510(k) SUMMARY

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1.0 Submitter:

DEC 3 0 2002

Name:	WRP Asia Pacific Sdn Bhd
Address:	Lot 1, Jalan 3, Kawasan Perushaan Bandar Baru Salak Tinggi,43900 Sepang, Selangor Darul Ehsan, MALAYSIA
Phone No.:	+60 3 8706 1486
Fax No.:	+60 3 8706 1485

1 3 DEC 2002 Date of Summary Prepared:

2.0 Contact Person:

Name:	Mr. Terence Lim
Phone No.:	+60 3 8706 1486
Fax No.:	+60 3 8706 1485

3.0 Modified Device Identification:

Trade Name:	1)	Comfit, and
	2)	Multiple or Customers' Trade Name
Device Name:	Powder Free Polymer Coated Green Neoprene SurgicalGloves, Sterile
Common Name:	Surgical Gloves
Classification Name:	Surgeon's Gloves (per 21 CFR 878.4460)

4.0 Identification of the Legally Marketed Device:

Class I Powder Free synthetic rubber latex surgeon's gloves, 79KGO, that meets all the requirements of ASTM standard D 3577 - 01a22 Type 2 and FDA 21 CFR 800.20.

Description of Device Modification: 5.0

The Powder Free Polymer Coated Green Neoprene Surgical Gloves, Sterile is equivalent to the existing model, i.e. Profeel Powder Free Polymer Coated Neoprene Surgical Gloves, Sterile which had submitted and cleared under 510(k) number K003019.

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Image /page/1/Picture/0 description: The image shows a logo with the letters "WRP" in white, set against a black, hexagonal background. The letters are bold and sans-serif, filling most of the space within the hexagon. The logo has a simple, clean design, making it easily recognizable.

WRP Asia Pacific Sdn Bhd

The difference in this submission is:

Change of colour additive used, i.e. Green a)
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The modification of colour does not affect the intended use of the device as well as it does not affect its safety and effectiveness. The indication for use and proposed labeling for the device are illustrated in subsequent sections.

The Powder Free Polymer Coated Green Neoprene Surgical Gloves, Sterile meets all the requirements of ASTM standard D 3577 -- 01a52 and FDA 21 CFR 800.20.

6.0 Intended Use of the Device:

7.0 Summary of Technological Characteristics for the Modified Device:

The Powder Free Polymer Coated Green Neoprene Surgical Gloves, Sterile are summarized with the following technological characteristics compared to ASTM or equivalent standards.

CHARACTERISTICS	STANDARDS	DEVICEPERFORMANCE
Dimensions	ASTM D 3577 - 01aE2	Meets
Physical Properties	ASTM D 3577 - 01aE2	Meets
Freedom from pinholes	ASTM D 3577 - 01aE2FDA 21 CFR 800.20	Meets
Powder Residual	ASTM D 6124 - 01	Meets< 2 mg/glove

8.0 Conclusion:

The Powder Free Polymer Coated Green Neoprene Surgical Gloves, Sterile will perform according to the glove performance standards referenced in section 7 above and meet ASTM standards, and FDA requirements for waterleak test on pinhole AQL. Consequently, this device is substantially equivalent to currently marketed devices.

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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features an abstract image of an eagle with three stripes representing the three levels of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

9200 Corporate Boulevard Rockville MD 20850

Mr. Terence Lim Associate Manager, RA/QA WRP Asia Pacific Sdn Bhd Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak Tinggi, 43900 Sepang, Selangor Darul Ehsan, MALAYSIA

Re: K024130

Trade/Device Name: Powder Free Polymer Coated Green Neoprene Surgical Gloves, Sterile Regulation Number: 21 CFR 878.4460 Regulation Name: Surgical Gloves Regulatory Class: I Product Code: KGO Dated: December 13, 2002 Received: December 16, 2002

Dear Mr. Lim:

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. Lim

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 vou desire specific advice for your device on our labeling regulation (21 CFR Part 801). 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/cdrh/dsma/dsmamain.html

Sincerely yours,

Timothy A. Ulatowski

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Asia Pacific Sdn Bhd

INDICATIONS FOR USE

Applicant:

WRP Asia Pacific Sdn Bhd

510(k) Number (if known):

K024130

Device Name:

POWDER FREE POLYMER COATED GREEN NEOPRENE SURGICAL GLOVES, STERILE

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Indications For Use:

The surgical glove is a device made of synthetic latex intended to be worn by surgeons and/or operating room personnel to protect a surgical wound from contamination.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use(Per 21 CFR 801.109)	OR	Over-The-Counter
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Clean S. Lim
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices

510(k) Number	K024130
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Valur Dartnor In Dratarting

Regulation Number and Section

§ 878.4460 Non-powdered surgeon's glove.

(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's 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).