The Powder Free Green Neoprene Surgical Glove, Sterile with Aloe Vera is 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.

The surgeon's glove is a device made of synthetic 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 Neoprene Surgical Glove, Sterile with Aloe Vera meets all the requirements of ASTM standard D 3577 - 01a22 and FDA 21 CFR 800.20.

AI/ML Overview

This document describes the process for obtaining 510(k) clearance for the WRP Asia Pacific Sdn Bhd "Powder Free Green Neoprene Surgical Glove, Sterile with Aloe Vera". The clearance is based on the device meeting established performance standards and being substantially equivalent to legally marketed predicate devices.

Here's the breakdown of the acceptance criteria and the "study" that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

Characteristics	Standards	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
Powder-Free	ASTM D 6124 - 01	Meets (< 2 mg/glove)
Biocompatibility	Primary Skin Irritation in Rabbits	Passes (Not a primary skin irritant)
Biocompatibility	Dermal Sensitization	Passes (Not a contact sensitizer)

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

The document does not explicitly state the specific sample sizes used for each individual performance test (e.g., how many gloves were tested for pinholes, or how many rabbits were used for biocompatibility testing). However, it implies that the testing was conducted according to the methodologies outlined in the referenced ASTM standards and FDA regulations, which would inherently dictate minimum sample sizes for statistical validity.

Provenance: All testing appears to be internal to the manufacturer (WRP Asia Pacific Sdn Bhd) or conducted by third-party labs on behalf of the manufacturer, to demonstrate compliance with international and US standards. The country of origin for the data (and manufacturing) is Malaysia.
Retrospective or Prospective: The testing would be considered prospective as it was conducted specifically to demonstrate compliance for this device prior to its submission for market clearance.

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

This information is not provided because the "ground truth" for the device's performance is not based on expert consensus of medical images or clinical outcomes, but rather on objective, measurable physical and chemical properties of the glove. The "experts" in this context would be the technicians and scientists performing the ASTM and FDA-mandated tests, adhering to established laboratory protocols.

For example:

For Dimensions and Physical Properties, the 'ground truth' is the quantitative measurements taken and compared against the numerical limits specified in ASTM D 3577. The experts are the lab technicians and engineers performing these measurements.
For Freedom from pinholes, the 'ground truth' is the absence of leaks when tested according to ASTM D 3577 (water leak test) and FDA 21 CFR 800.20 (Acceptable Quality Level for defects). The experts are the quality control personnel and lab technicians conducting these tests.
For Powder-Free, the 'ground truth' is the measured powder residue, which must be less than 2 mg/glove as per ASTM D 6124. The experts are lab technicians performing gravimetric analysis.
For Biocompatibility, the 'ground truth' is the observed biological response in animal models (rabbits) or in vitro tests. The experts are trained toxicologists and lab personnel specializing in biocompatibility assessments.

4. Adjudication Method for the Test Set:

Not applicable in the human-centric sense (e.g., 2+1, 3+1 for medical image interpretation). The "adjudication" is inherent in the standardized test methods themselves. The results meet or fail the specified criteria. Any discrepancies would involve retesting or investigation into the testing methodology, but not a consensus process among human evaluators in the same way clinical data is adjudicated.

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

Not applicable. This is a medical device (surgical glove), not an AI/software device that assists human readers in interpreting medical data. Therefore, there is no concept of "human readers improve with AI vs without AI assistance."

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:

Not applicable. This is a physical medical device (surgical glove), not an algorithm or AI system. The performance is assessed directly on the product's physical and chemical attributes, not on an algorithm's output.

7. Type of Ground Truth Used:

The ground truth used is primarily objective, measurable physical and chemical properties defined by recognized industry standards (ASTM) and regulatory requirements (FDA 21 CFR 800.20), and biocompatibility testing outcomes in animal models.

8. Sample Size for the Training Set:

Not applicable. This is a physical medical device, not a machine learning model. There is no "training set" in the context of AI or algorithm development. The manufacturing process is refined through quality control and process validation, but this is distinct from an AI training set.

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

Not applicable, as no training set (for AI/ML) is involved. The "ground truth" for ensuring consistent product quality in manufacturing is established through adherence to Good Manufacturing Practices (GMP) and ongoing quality control checks, which verify that the manufactured gloves meet the specified standards.

Summary

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KO22444

SEP 1 7 2002

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 1485

22 JUL LUUZ 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 Neoprene Surgical Glove, Sterile withAloe Vera.
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 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.

5.0 Description of The Device:

The Powder Free Green Neoprene Surgical Glove, Sterile with Aloe Vera meets all the requirements of ASTM standard D 3577 - 01a22 and FDA 21 CFR 800.20.

Page 1 of 3

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6.0 Intended Use of the Device:

7.0 Summary of The Technological Characteristics of The Device:

The Powder Free Green Neoprene Surgical Gloves, Sterile with Aloe Vera 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-Free	ASTM D 6124 - 01	Meets< 2 mg/glove
Biocompatability	Primary Skin Irritation inRabbits	Passes(Not a primary skin irritant)
Biocompatability	Dermal Sensitization	Passes(Not a contact sensitizer)

8.0 Substantial Equivalent Based on Assessment of 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.

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K02444

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 Neoprene Surgical Glove, Sterile with Aloe Vera 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Yue Wah Chow Head of Department OA/RA Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak Tinggi, 43900 Sepang Selangor Darul Ehsan, MALAYSIA

Re: K022444

Trade/Device Name: Powder Free Green Neoprene Surgical Gloves, Sterile with Aloe Vera 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 vour 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.qov/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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INDICATIONS FOR USE

Applicant:

510(k) Number (if known):

Device Name:

WRP Asia Pacific Sdn Bhd 02244

POWDER FREE GREEN NEOPRENE SURGICAL GLOVES, STERILE WITH ALOE VERA

Indications For Use:

The surgeon's glove is a device made of synthetic 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)

Clive S. Lam

sion Sign-Olly ontrol. Dental D

510(k) Number: K022444

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

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).