The Powder Free Polymer Coated Latex Surgical Gloves, Sterile (Protein Labeling Claim) 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 Polymer Coated Latex Surgical Gloves, Sterile (Protein Labeling Claim) meets all the requirements of ASTM standard D 3577 - 0151 and FDA 21 CFR 800.20.

AI/ML Overview

The document describes the acceptance criteria and performance of Powder Free Polymer Coated Latex Surgical Gloves. It is a 510(k) summary for a medical device.

1. Table of Acceptance Criteria and Reported Device Performance:

CHARACTERISTICS	STANDARDS	ACCEPTANCE CRITERIA (from Standards)	REPORTED DEVICE PERFORMANCE
Dimensions	ASTM D 3577 - 01E1	As per ASTM D 3577 - 01E1	Meets
Physical Properties	ASTM D 3577 - 01E1	As per ASTM D 3577 - 01E1	Meets
Freedom from pinholes	ASTM D 3577 - 01E1 & FDA 21 CFR 800.20	As per ASTM D 3577 - 01E1 & FDA 21 CFR 800.20	Meets
Powder-Free	ASTM D 6124 - 01	< 2 mg/glove	< 2 mg/glove (Meets)
Protein Level	ASTM D 5712 – 99	< 50 $\mu$g/g	< 50 $\mu$g/g (Meets)
Biocompatibility (Primary Skin Irritation in Rabbits)	As per standard (not explicitly named but implied)	Passes (Not a primary skin irritant)	Passes (Not a primary skin irritant)
Biocompatibility (Dermal Sensitization)	As per standard (not explicitly named but implied)	Passes (Not a contact sensitizer)	Passes (Not a contact sensitizer)

Regarding the studies that prove the device meets acceptance criteria:

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical trials for effectiveness. The "study" here refers to the testing performed to show compliance with established standards.

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

The document does not explicitly state the sample sizes used for each specific test (e.g., dimensions, pinholes, protein level). These tests are typically performed on a statistically representative sample of gloves from manufacturing lots, as outlined in the respective ASTM standards.
Data Provenance: The tests are described as non-clinical performance data. The submitter is WRP Asia Pacific Sdn Bhd, located in Malaysia, suggesting the testing was likely conducted in Malaysia or by a contracted lab. The data is retrospective in the sense that it's reported from tests performed on already manufactured gloves.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This question is not applicable to this type of device and study. The "ground truth" for these tests is defined by established scientific and engineering standards (ASTM and FDA regulations), not by expert consensus readings of, for example, medical images. The experts involved would be the engineers and quality control personnel performing the tests and interpreting the results against the defined standards. Their qualifications would be in metrology, chemistry, materials science, and quality assurance, not clinical expertise like radiology.

4. Adjudication method for the test set:

This question is not applicable. Adjudication methods like "2+1" typically refer to reconciling disagreements among multiple human readers interpreting data. Here, the assessment involves objective measurements against predefined criteria in established standards.

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:

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices, not for a physical product like surgical gloves.

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

No, a standalone algorithm performance study was not done. This device is a passive physical product and does not involve any algorithms or AI.

7. The type of ground truth used:

The "ground truth" for the device's performance is established by the specified ASTM standards and FDA regulations for each characteristic (e.g., ASTM D 3577 for dimensions, physical properties, and freedom from pinholes; ASTM D 6124 for powder-free; ASTM D 5712 for protein level). For biocompatibility, the ground truth is determined by the results of standardized animal irritation and sensitization tests.

8. The sample size for the training set:

This question is not applicable. There is no "training set" in the context of this device. A training set is used for machine learning models, which are not involved here. The data comes from quality control testing of manufacturing batches.

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

This question is not applicable as there is no training set.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for WRP Asia Pacific Sdn Bhd. The logo consists of the letters "WRP" in white on a black rounded rectangle. To the right of the logo is the text "WRP Asia Pacific Sdn Bhd" in black. Below the text is the number "147817 V".

Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak Tinggi, 43900 Sepang, Selangor Darul Ehsan, MALAYSIA

JAN 2 3 2002

510(k) SUMMARY

TEL +60-3-8706 1486 FAX +60-3-8706 1485 EML cyw_wrp@wrpworld.com URL www.wrpworld.com

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

28 DEC 2001 Date of Summary Prepared:

Contact Person: 2.0

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. Profeel and2. Multiple or Customer's Trade Name
Device Name:	Powder Free Polymer Coated Latex Surgical Gloves, Sterile(Protein Labeling Claim) (50 microgram or Loss)
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 - 0111 Type 1 and FDA 21 CFR 800.20.

5.0 Description of The Device:

The Powder Free Polymer Coated Latex Surgical Gloves, Sterile (Protein Labeling Claim) meets all the requirements of ASTM standard D 3577 - 0151 and FDA 21 CFR 800.20.

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WRP Asia Pacific Sdn Bhd

Intended Use of the Device: 6.0

Summary of The Technological Characteristics of The Device: 7.0

The Powder Free Polymer Coated Latex Surgical Gloves, Sterile (Protein Labeling Claim) are summarized with the following technological characteristics compared to ASTM or equivalent standards.

CHARACTERISTICS	STANDARDS	DEVICEPERFORMANCE
Dimensions	ASTM D 3577 - 01E1	Meets
Physical Properties	ASTM D 3577 - 01E1	Meets
Freedom from pinholes	ASTM D 3577 - 01E1FDA 21 CFR 800.20	Meets
Powder-Free	ASTM D 6124 - 01	Meets< 2 mg/glove
Protein Level	ASTM D 5712 – 99	< 50 $\mu$ g/g
Biocompatability	Primary Skin Irritation inRabbitsDermal Sensitization	Passes(Not a primary skin irritant)Passes(Not a contact sensitizer)

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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.

Substantial Equivalent Based on Assessment of Clinical Performance Data 9.0

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 Polymer Coated Latex Surgical Gloves, Sterile (Protein Labeling Claim) 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 3 2002

Mr. Yue W. Chow Head of Department, QA/RA WRP Asia Pacific Sdn. Bhd. Lot 1, Jalan 3, Kawasan Perusahaan 43900 Sepang, Selangor Darul Ehsan, MALAYSIA

Re: K020019

Trade/Device Name: Powder-Free Polymer Coated Latex Surgical Gloves, Sterile with Protein Labeling Claim (50 Micrograms or Less) Regulation Number: 878.4470 Regulation Name: Surgeon's Gloves Regulatory Class: I Product Code: KGO Dated: December 28, 2001 Received: January 3, 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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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,

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

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INDICATIONS FOR USE

Applicant:	WRP Asia Pacific Sdn Bhd
510(k) Number (if known):	K020019
Device Name:	POWDER FREE POLYMER COATED LATEXSURGICAL GLOVES, STERILE (PROTEINLABELING 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 (Per 21 CFR 801.109) Over-The-Counter

Olu S. Lim

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number _ 0

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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).