The Powder Free Latex Surgical Gloves, Sterile, Coated with Aloe Vera and with Protein Content Labeling Claim (50 micrograms or less) are made of natural 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.

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

Device Description

The Powder Free Latex Surgical Gloves, Sterile, Coated with Aloe Vera and with Protein Content Labeling Claim (50 micrograms or less) is equivalent to the exiting model, i.e. Powder Free Green Latex Surgical Gloves, Sterile with Aloe Vera and Protein Content Labeling Claim (50 micrograms or less) which had submitted and cleared under 510(k) number K022442.

The difference in this submission is:

No colour additive is added. a)

The Powder Free Latex Surgical Gloves, Sterile, Coated with Aloe Vera and with Protein Content Labeling Claim (50 micrograms or less) meets all the requirements of ASTM standard D 3577 - 01a52 and FDA 21 CFR 800.20.

AI/ML Overview

The provided document is a 510(k) summary for a medical device, specifically Powder Free Latex Surgical Gloves, Sterile, Coated with Aloe Vera and with Protein Content Labeling Claim (50 micrograms or less).

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Characteristic	Standard (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	Meets (Waterleak test on pinhole AQL)
Powder Residual	ASTM D 6124 - 01	Meets (< 2 mg/glove)
Protein Level	ASTM D 5712 – 99	< 50 µg/g
Biocompatibility: Primary Skin Irritation	Primary Skin Irritation in Rabbits	Passes (Not a primary skin irritant)
Biocompatibility: Dermal Sensitization	Dermal Sensitization	Passes (Not a contact sensitizer)

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the exact sample sizes used for the various tests (Dimensions, Physical Properties, Freedom from pinholes, Powder Residual, Protein Level, Biocompatibility).

The provenance of the data is not explicitly stated from a geographical perspective, but the tests were performed by the manufacturer, WRP Asia Pacific Sdn Bhd, located in Malaysia. The nature of the tests (e.g., physical property testing, chemical analysis, biocompatibility animal studies) generally implies that they were conducted specifically for this device (prospective testing) rather than being retrospective analysis of existing data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This type of device (surgical gloves) does not typically involve "experts" in the sense of clinical reviewers establishing ground truth for diagnostic accuracy, as it's a barrier device. The "ground truth" is established by the specified ASTM standards and FDA regulations. The testing involves adherence to these standards, not expert interpretation of clinical data in a test set.

For the biocompatibility tests (Primary Skin Irritation in Rabbits and Dermal Sensitization), these test methods are standardized and typically conducted in specialized laboratories following Good Laboratory Practice (GLP) guidelines. The "experts" in this context would be the toxicologists and laboratory personnel qualified to conduct and interpret these specific animal studies. Their number and specific qualifications are not detailed in this summary.

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1, 3+1) are relevant for studies involving human interpretation or clinical outcomes where there might be disagreement. This is not applicable to the testing performed for surgical gloves, which involves objective measurements against established engineering and chemical standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. This type of study is typically performed for diagnostic or assistive AI devices where human readers interpret medical images or data. Surgical gloves are a barrier protection device, and their effectiveness is evaluated through physical, chemical, and biocompatibility testing, not through human reader performance studies.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is not an algorithm or software. It is a physical medical device (surgical glove).

7. Type of Ground Truth Used

The ground truth used for this device is based on:

Established Industry Standards: ASTM D 3577 - 01aE2 (Dimensions, Physical Properties, Freedom from pinholes), ASTM D 6124 - 01 (Powder Residual), ASTM D 5712 – 99 (Protein Level).
Regulatory Requirements: FDA 21 CFR 800.20 (Freedom from pinholes).
Standardized Biocompatibility Test Procedures: Primary Skin Irritation in Rabbits and Dermal Sensitization.

This is a form of objective, standardized measurement against pre-defined thresholds rather than clinical outcomes or expert consensus on a diagnostic finding.

8. Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As stated above, this device does not involve a training set.

Summary

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K032464

WRP Asia Pacific Sdn Bhd 1 コフ良さアレ

AUG 2 2 2003

SPECIAL 510(k) SUMMARY

1.0 Submitter:

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 1557

Date of Summary Prepared: 0 7 AUG 2003

2.0 Contact Person:

Name:	Mr. Terence Lim
Phone No .:	+60 3 8706 1486
Fax No .:	+60 3 8706 1557

3.0 Modified Device Identification:

Trade Name:	1) Aloetouch, and2) Multiple or Customers' Trade Name
Device Name:	Powder Free Latex Surgical Gloves, Sterile, Coated with Aloe Vera and with Protein Content Labeling Claim (50 micrograms or less)
Common Name:	Surgical Gloves
Classification Name:	Surgeon's Gloves (per 21 CFR 878.4460)

Identification of the Legally Marketed Device: 4.0

Class I Powder Free natural rubber latex surgeon's gloves, 79KGO, that meets all the requirements of ASTM standard D 3577 - 01a22 Type 1 and FDA 21 CFR 800.20.

Description of Device Modification: 5.0

The Powder Free Latex Surgical Gloves, Sterile, Coated with Aloe Vera and with Protein Content Labeling Claim (50micrograms or less) is equivalent to the exiting model, i.e. Powder Free Green Latex Surgical Gloves, Sterile with Aloe Vera and Protein Content Labeling Claim (50 micrograms or less) which had submitted and cleared under 510(k) number K022442.

Page 1 of 3

Your Partner In Protection"

ATTACHMENT 1

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K032464

WRP Asia Pacific Sdn Bhd '

The difference in this submission is:

1 4 7 8 1 7 V

No colour additive is added. a)
The modification of device 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.

Intended Use of the Device: 6.0

Summary of Technological Characteristics for the Modified Device: 7.0

The Powder Free Latex Surgical Gloves, Sterile, Coated with Aloe Vera and with Protein Content Labeling Claim (50 micrograms or less) 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
Protein Level	ASTM D 5712 – 99	< 50 µg/g
Biocompatability	Primary Skin Irritation inRabbits	Passes(Not a primary skin irritant)
	Dermal Sensitization	Passes(Not a contact sensitizer)

Page 2 of 3

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Image /page/2/Picture/0 description: The image shows the logo for WRP Asia Pacific Sdn Bhd. The logo consists of the letters "WRP" in a bold, sans-serif font, with the "WRP" on the right in a smaller font. Below the logo is the number "147817 V".

K032464

8.0 Conclusion:

The Powder Free Latex Surgical Gloves, Sterile, Coated with Aloe Vera and with Protein Content Labeling Claim (50 micrograms or less) 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.

Page 3 of 3

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle's head.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 2 2003

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: K032464

Trade/Device Name: Powder Free Latex Surgical Glove Sterile, Coated with Aloe Vera and with Protein Content Labeling Claim (50 Micrograms or less) Regulation Number: 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: August 7, 2003 Received: August 11, 2003

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 (QS) 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), please contact the Office of Compliance at (301) 594-4618. 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 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.

Susa Ruoser

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/5/Picture/0 description: The image shows the logo for WRP Asia Pacific Sdn Bhd. The logo consists of the letters "WRP" in a bold, stylized font, followed by the words "WRP Asia Pacific Sdn Bhd" in a smaller, but still prominent font. Below the company name is the number "147817 V".

INDICATIONS FOR USE

Applicant:

WRP Asia Pacific Sdn Bhd

510(k) Number (if known): KC32464

Device Name:

POWDER FREE LATEX SURGICAL GLOVES,
STERILE, COATED WITH ALOE VERA AND
WITH PROTEIN CONTENT LABELING CLAIM
(50 MICROGRAMS OR LESS)

Indications For Use:

The surgeon's glove is a device made of natural rubber 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)

Qian S. Lin

ion of Anesthesiology, General Hospital, on Control, Dental I

510(k) Number. K032464

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter
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Voire

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).