The Powder Free Latex Examination Glove, Sterile (Protein Content Labeling) is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Device Description

The Powder Free Latex Examination Glove, Sterile (Protein Content Labeling) meets all the requirements of ASTM standard D 3578 - 01ε1 and FDA 21 CFR 800.20.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the device:

Device: Powder Free Latex Examination Glove, Sterile (Protein Content Labeling)

1. Table of Acceptance Criteria and Reported Device Performance:

Characteristics	Acceptance Criteria (Standards)	Reported Device Performance
Dimensions	ASTM D 3578 - 01ε1	Meets
Physical Properties	ASTM D 3578 - 01ε1	Meets
Freedom from pinholes	ASTM D 3578 - 01ε1 & FDA 21 CFR 800.20	Meets
Powder-Free	ASTM D 6124 - 00	< 2 mg/glove
Protein Level	ASTM D 5712 - 99	< 50 μg/g
Biocompatibility	Primary Skin Irritation in Rabbits & Dermal Sensitization	Passes (Not a primary skin irritant & Not a contact sensitizer)

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

Sample size: Not explicitly stated. The document refers to "Device Performance" for various characteristics, implying testing was conducted, but the specific number of gloves or samples tested for each characteristic is not provided.
Data provenance: Not explicitly stated, but the submission is from a Malaysian company (WRP Specialty Products Sdn. Bhd.). The testing appears to be internal to the manufacturer or conducted by a third-party lab on behalf of the manufacturer, to demonstrate compliance with international standards (ASTM and FDA regulations). The data would be considered retrospective in a regulatory submission context, as it's presented after the tests were performed.

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

This information is not applicable. The device is a medical glove, and its performance is assessed against recognized engineering and safety standards (ASTM standards and FDA regulations) through physical and chemical testing, rather than through expert interpretation of a specific condition or imaging.
The "ground truth" for these tests would be the measured results from the laboratory testing, compared against the specified limits in the standards.

4. Adjudication method for the test set:

This is not applicable as the "test set" involves physical and chemical property measurements against pre-defined standards, not subjective assessments requiring expert adjudication.

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 MRMC study was done. This type of study is relevant for diagnostic devices that involve human interpretation (e.g., radiology AI), not for basic medical devices like examination gloves.

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

No standalone algorithm performance study was done. This concept is not applicable to a medical examination glove.

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

The ground truth for the device performance claims is established by objective measurements and laboratory testing against specified physical, chemical, and biological criteria defined in recognized standards (ASTM D 3578-01ε1, ASTM D 6124-00, ASTM D 5712-99) and FDA regulations (21 CFR 800.20).
For biocompatibility, the ground truth is established by standard biological evaluation tests (Primary Skin Irritation in Rabbits, Dermal Sensitization), which result in a "Pass" or "Fail" based on observed reactions.

8. The sample size for the training set:

This is not applicable. Medical gloves do not typically involve a "training set" in the context of machine learning or AI models. The testing is for product quality and safety validation, not for training an algorithm.

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

This is not applicable, as there is no "training set." The performance is validated against established industry and regulatory standards.

Summary

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JUN 1 1 2002

510(k) Summary

1.0	Submitter:	K021561
	Name	WRP Specialty Products Sdn. Bhd.
	Address	Lot 11, Jalan 2, Kawasan Perusahaan Bandar Baru SalakTinggi, 43900 Sepang, Selangor Darul Ehsan, MALAYSIA
	Phone No.	+60 3 8706 9788
	Fax No.	+60 3 8706 5022

Date of Summary Prepared April 8, 2002 :

2.0 Contact Person:

Name:	Mr. V. Nadarajan
Phone No.:	+60 3 8706 9788
Fax No.:	+60 3 8706 5020

3.0 Name of the device:

Proprietary or Trade Name	: 1.	Dermagrip, and
	: 2.	Multiple or Customer's Trade Name
Classification Name	:	Patient Examination Gloves (per 21 CFR 880.6250)
Device Name	:	Powder Free Latex ExaminationGlove, Sterile (Protein Content Labeling)

4.0 Identification of The Legally Marketed Device:

Class I patient examination gloves, 80LYY, powder free, that meets all the requirements of ASTM standard D 3578 - 0161 and FDA 21 CFR 800.20.

5.0 Description of The Device:

The Powder Free Latex Examination Glove, Sterile (Protein Content Labeling) meets all the requirements of ASTM standard D 3578 - 01°1 and FDA 21 CFR 800.20.

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6.0 Intended Use of the Device:

The Powder Free Latex Examination Glove, Sterile (Protein Content Labeling) are disposable devices intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Summary of the Technological Characteristics of the Device: 7.0

The Powder Free Latex Examination Glove, Sterile (Protein Content Labeling) are summarized with the following technological characteristics compared to ASTM or equivalent standards.

Characteristics	Standards	Device Performance
Dimensions	ASTM D 3578 - 01ε1	Meets
Physical Properties	ASTM D 3578 - 01ε1	Meets
Freedom from pinholes	ASTM D 3578 - 01ε1FDA 21 CFR 800.20	Meets
Powder-Free	ASTM D 6124 - 00	< 2 mg/glove
Protein Level	ASTM D 5712 - 99	< 50 μg/g
Biocompatability	Primary Skin Irritation inRabbitsDermal Sensitization	Passes(Not a primary skin irritant)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.

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 Latex Examination Glove, Sterile (Protein Content Labeling) 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/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, with flowing lines suggesting movement or progress. The profiles are arranged in a row, slightly overlapping each other. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the image.

JUN 1 1 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. V. Nadarajan Manager QA/RA Lot 11, Jalan 2, Kawasan Perusahaan Bandar Baru Salak Tinggi, 43900 Sepang Selangor Darul Ehsan, MALAYSIA

Re: K021561

Trade/Device Name: Dermagrip and Multiple Powder Free Latex Examination Glove Sterile with Protein Content Labeling Claim (50 Micrograms of Less) Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: April 8, 2002 Received: May 13, 2002

Dear Mr. V. Nadarajan:

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. V. Nadarajan

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 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 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 Specialty Products Sdn Bhd
510(k) Number (if known):	K021561
Device Name	POWDER FREE LATEX EXAMINATIONGLOVE, STERILE(PROTEIN CONTENT LABELING)

Indications For Use:

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

Olin S. Liven

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number __ r O'

Regulation Number and Section

§ 880.6250 Non-powdered patient examination glove.

(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination 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). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.