The Powder Free Green Latex Surgical Gloves, Sterile with Aloe Vera and 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 Green Latex Surgical Gloves, Sterile with Aloe Vera and Protein Content Labeling Claim (50 micrograms or less) meets all the requirements of ASTM standard D 3577-01a"2 and FDA 21 CFR 800.20.

AI/ML Overview

The provided text describes a 510(k) premarket notification for "Powder Free Green Latex Surgical Gloves, Sterile with Aloe Vera and Protein Content Labeling Claim (50 micrograms or less)". This document is for a medical device that is not an AI/ML powered device, therefore, many of the requested fields are not applicable.

Here's a breakdown based on the information provided:

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 - 01aE2FDA 21 CFR 800.20	Meets
Powder-Free	ASTM D 6124 - 01	Meets2 mg/glove maximum
Protein Level	ASTM D 5712 - 95	< 50 µg/g
Biocompatibility	Primary Skin Irritation inRabbits	Passes(Not a primary skin irritant)
	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 size used for each test. It refers to established ASTM standards (like D 3577-01aE2, D 6124-01, D 5712-95) and FDA regulations (21 CFR 800.20) for the testing methodologies. These standards typically define the appropriate sample sizes for such tests.

The data provenance is not explicitly stated as "country of origin" for testing data, but the manufacturer is WRP Asia Pacific Sdn Bhd, based in Malaysia. The testing aligns with US FDA regulations and ASTM standards, which are internationally recognized. The testing is assumed to be prospective as it's part of a premarket submission for a new device.

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

Not applicable. This is not an AI/ML device that requires human expert consensus for ground truth. The "ground truth" for glove performance is established by the specified ASTM standards and FDA regulations.

4. Adjudication Method for the Test Set

Not applicable. This is not an AI/ML device that requires adjudication of expert opinions. The performance is measured against objective, published standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

Not applicable. This device is a surgical glove, not an AI/ML system.

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

Not applicable. This device is a physical product (surgical gloves), not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for this device is based on established industry standards and regulatory requirements. Specifically:

Physical and dimensional properties are compared against ASTM D 3577-01aE2.
Freedom from pinholes is assessed against ASTM D 3577-01aE2 and FDA 21 CFR 800.20 (water leak test, AQL).
Powder content is measured against ASTM D 6124-01.
Protein level is measured against ASTM D 5712-95.
Biocompatibility is assessed through "Primary Skin Irritation in Rabbits" and "Dermal Sensitization" tests, which are standard toxicological assessments.

8. The Sample Size for the Training Set

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

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

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

Summary

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VRP Asia Pacific Sdn Bhd 1 4 7 8 1 7 V

KO22442

510(k) SUMMARY

1.0 Submitter:

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

22 JUL 2002 Date of Summary Prepared:

2.0 Contact Person:

Name:	Mr. Yue Wah, CHOW
Phone No.:	+60 3 8706 1486
Fax No.:	+60 3 8706 1485

3.0 Name of the device:

Trade Name:	1. Aloetouch, and2. Multiple or Customer's Trade Name
Device Name:	Powder Free Green Latex Surgical Gloves, Sterile with AloeVera and Protein Content Labeling Claim (50 micrograms orless)
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 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.

5.0 Description of The Device:

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Image /page/1/Picture/9 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, enclosed in a black oval shape. To the right of the logo is the company name, "WRP Asia Pacific Sdn Bhd," also in a bold, sans-serif font. Below the company name is the number "147817 V".

K02242

Intended Use of the Device: 6.0

7.0 Summary of The Technological Characteristics of The Device:

The Powder Free Green Latex Surgical Gloves, Sterile with Aloe Vera and Protein Content Labeling Claim (50 micrograms or less) are summarized with the following technological characteristics compared to ASTM or equivalent standards.

CHARACTERISTICS	STANDARDS	DEVICE PERFORMANCE
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-Free	ASTM D 6124 - 01	Meets2 mg/glove maximum
Protein Level	ASTM D 5712 - 95	< 50 µg/g
Biocompatability	Primary Skin Irritation inRabbits	Passes(Not a primary skin irritant)
	Dermal Sensitization	Passes(Not a contact sensitizer)

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Image /page/2/Picture/0 description: The image contains a sequence of handwritten digits and letters. The sequence starts with the letters 'K0', followed by the numbers '22442'. The handwriting style is cursive, with some connections between the characters.

Image /page/2/Picture/1 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, enclosed in a black oval shape. To the right of the oval is the text "WRP Asia Pacific Sdn Bhd" in a similar font. Below the text is the number "147817V".

Substantial Equivalent Based on Assessment of Non-Clinical Performance Data 8.0

The performance test data of the non-clinical tests that support a determination of substantial equivalence is the same as mentioned immediately above.

9.0 Substantial Equivalent Based on Assessment of Clinical Performance Data

Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.

10.0 Conclusion

It can be concluded that the Powder Free Green Latex Surgical Gloves, Sterile with Aloe Vera and 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 water leak test on pinhole AQL. Consequently, this device is substantially equivalent to currently marketed devices.

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Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around it. Inside the circle is a stylized symbol consisting of three abstract human profiles facing to the right, with flowing lines connecting them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

5 2002 SEP

Mr. Yue Wah Chow Head of Department, QA/RA WRP Asia Pacific Sdn. Bhd. Lot 1, Jalan 3, Kawasan Persahaan Bander Baru Salak Tinggi, 43900 Sepang, Selangor Darul Ehsan, MALAYSIA

Re: K022442

Trade/Device Name: Powder Free Green Latex Surgical Gloves, Sterile with Aloe Vera and Protein Content Labeling Claim ( 50 Micrograms or Less ) Regulation Number: 878.4460 Regulation Name: Surgeon's Gloves Regulatory Class: I Product Code: KGO Dated: July 22, 2002 Received: July 25, 2002

Dear Mr. Chow:

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. Chow

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 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/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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Image /page/5/Picture/0 description: The image shows a logo with the letters "WRP" in bold, white font against a black, rounded rectangular background. The letters are large and take up most of the space within the shape. The logo has a simple, clean design and appears to be for an organization or company with the initials "WRP".

WRP Asia Pacific Sdn Bhd

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INDICATIONS FOR USE

KO22442

Applicant:

WRP Asia Pacific Sdn Bhd

510(k) Number (if known):

Device Name:

POWDER FREE GREEN LATEX SURGICAL GLOVES, STERILE WITH ALOE VERA AND 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)

Prescription Use	OR	Over-The-Counter
(Per 21 CFR 801.109)

(Division Sign-Off)

Division of Anesthesiology, General Hospital,

Infection Control, Dental Devices

510(k) Number:	K022442
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Page 1 of 1

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).