A powder free patient examination glove is a disposable device intended for medical purposes that is worn on the examiners hand or finger to prevent contamination between patient and examiner.

Device Description

Powder free Latex Examination Glove is a class I device having product code LYY. It is a disposable device that meets all requirements of ASTM D3578-05.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the 'KS-CARE' Powder Free Polymer Coated Latex Examination Glove:

The provided document is a 510(k) Summary for a medical device: 'KS-CARE' Powder Free Polymer Coated Latex Examination Glove with Protein Content labeling Claim (50 Micrograms or Less). This type of submission aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving novel safety and effectiveness through extensive clinical trials.

The "study" in this context refers to the testing performed against recognized standards and comparative data with predicate devices to demonstrate the new device is as safe and effective as existing ones.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are largely derived from ASTM D3578-05 (Standard Specification for Rubber Examination Gloves) and in comparison to predicate devices.

Acceptance Criteria (from ASTM D3578-05 / Predicate Comparison)	Reported Device Performance (KS-CARE Powder Free Polymer Coated Latex Examination Glove)
Physical Dimensions
Width (size Medium)	95 +/- 5 mm (Matches predicate 2, within range of predicate 1 (90-97mm))
Overall Length	Min 240 mm (Matches predicate 2, min 240mm; predicate 1 is 241mm)
Palm Thickness	Min 0.08 mm (Lower than predicates (0.10mm, 0.10mm))
Finger Thickness	Min 0.08 mm (Lower than predicates (0.13mm, 0.10mm))
Physical Properties
Tensile Strength Pre-aging (min)	Min 18 Mpa (Matches predicate 2, lower than predicate 1 (27 Mpa))
Tensile Strength After-aging (min)	Min 14 Mpa (Matches predicate 2, lower than predicate 1 (25.8 Mpa))
Ultimate Elongation Pre-aging (min)	Min 650% (Matches predicate 2, lower than predicate 1 (830%))
Ultimate Elongation After-aging (min)	Min 500% (Matches predicate 2, lower than predicate 1 (730%))
Biocompatibility
Biocompatibility (Meets relevant standards)	YES (Passes)
Skin Irritation Test	Pass
Dermal Sensitization Test	Pass
Quality/Defect Levels
Acceptable Quality Level (AQL) (Pinhole, typically)	1.5% (Better than predicate 1 (2.5%), no info for predicate 2)
Chemical Residue
Residual Powder Content (max)	Max 2.0 mg/glove (Higher than predicate 1 (1.1 mg/glove), no info for predicate 2)
Residual Protein Level	< 50 µg/g (Different unit from predicate 1 (< 50 µg/dm2), no info for predicate 2)
Other Tests
Iodine Test	Passes

Note on "Minor difference": The document explicitly labels the Tensile Strength after aging as having a "Minor difference" compared to one predicate, indicating that while the measurement itself meets the minimum, the specific value is divergent from one of the predicate devices. However, it still meets the stated "Min 14 Mpa" acceptance criteria. The thickness and elongation values also show variation from predicates but generally meet the stated minimums.

Study Details:

This submission describes non-clinical performance testing and a comparison to predicate devices to establish substantial equivalence. It does not involve a multi-reader, multi-case study with human readers or an AI algorithm.

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

Test Set Sample Size: Not explicitly stated as a single "test set" in the context of clinical trials or AI evaluation. The testing performed involves samples of gloves taken from manufacturing lots. For example, for physical specifications and dimensions testing, the inspection level is S-2 with an AQL 4.0, and for pinholes, an AQL of 2.5 is used. These AQLs (Acceptance Quality Limit) specify the maximum percentage of defective units in a lot that can be considered acceptable.
Data Provenance: The data originates from internal testing conducted by the manufacturer, Koon Seng Sdn. Bhd., in Malaysia to demonstrate compliance with ASTM D3578-05a and other standards (biocompatibility). It is retrospective in the sense that these are manufacturing quality control tests, not a prospective clinical study specifically designed for this submission.

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

Not Applicable. For a medical examination glove, "ground truth" typically relates to objective measurements performed by laboratory technicians or validated testing equipment against established standards (e.g., ASTM standards for glove properties, ISO standards for biocompatibility). There are no "experts" in the sense of clinical specialists establishing a "ground truth" for interpretation, as would be the case for diagnostic imaging.

4. Adjudication Method for the Test Set:

Not Applicable. Adjudication methods (like 2+1 or 3+1) are used in studies where there's subjective interpretation by multiple human readers (e.g., radiologists) and a need to resolve discrepancies. The testing for this glove involves objective, quantitative measurements and pass/fail criteria based on standards.

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

No. This type of study is not relevant for a patient examination glove. An MRMC study would typically be used to assess the impact of an AI algorithm on human reader performance (e.g., in medical image interpretation).

6. Standalone (Algorithm Only) Performance Study:

No. This device is a physical product (a glove), not an algorithm or AI software. Therefore, a standalone algorithm performance study is not applicable.

7. Type of Ground Truth Used:

The "ground truth" for this device is based on objective, quantitative measurements against recognized industry standards (ASTM D3578-05a) and biocompatibility testing performed according to international standards. For example:
- Physical dimensions: Measured length, width, thickness.
- Physical properties: Measured tensile strength and elongation.
- Biocompatibility: Results from standardized tests for skin irritation and dermal sensitization.
- Defect levels: Based on accepted quality limits (AQL) which define the maximum allowable percentage of defects (e.g., pinholes).
- Chemical residues: Quantitative measurement of powder and protein content.

8. Sample Size for the Training Set:

Not Applicable. This is not an AI/machine learning device. Therefore, there is no "training set" in the context of algorithm development.

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

Not Applicable. (See point 8).

Summary

{0}------------------------------------------------

K093375

EXHIBIT #1

510(k) Summary

DEC - 2 2009

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

1. Applicant:

Koon Seng Sdn. Bhd. Ptd 16058. Kawasan Perindustrian Tangkak, Jalan Muar, 84900 Tangkak, Johor, Malaysia

2. Manufacturer:

Koon Seng Sdn. Bhd. Ptd 16058, Kawasan Perindustrian Tangkak, Jalan Muar, 84900 Tangkak, Johor, Malaysia

3. Submitter:

Mr. Jigar Shah Official Correspondent for Koon Seng Sdn. Bhd. Summary Prepared on: April 7, 2009

4. Address:

mdi Consultants, Inc. 55 Northern Blvd., Suite 200 Great Neck, New York 11021 Tel: 516-482-9001 Fax: 516-482-0186 jigar@mdiconsultants.com

5. Trade/proprietary Name:

'KS-CARE' Powder Free Polymer Coated Latex Examination Glove with Protein Content labeling Claim (50 Micrograms or Less).

6. Common Names: POWDER-FREE Patient Examination Glove

1. Classification name: Patient Examination Glove
1. Classification number: 21 CFR 880.6250

{1}------------------------------------------------

9. Device Description:

Powder free Latex Examination Glove is a class I device having product code LYY. It is a disposable device that meets all requirements of ASTM D3578-05.

10. Intended Use:

A powder free patient examination glove is a disposable device intended for medical purposes that is worn on the examiners hand or finger to prevent contamination between patient and examiner. These gloves are not intended to be used as a chemical barrier.

11. Substantial Equivalence Discussion:

A powder free patient examination glove is substantially equivalent to the predicate devices.

Characteristicandparameters	'KS-CARE'Powder FreePolymer CoatedLatexExaminationGlove withProtein Contentlabeling Claim(50 Microgramsor Less)	SGMP CompanyLtd. Powder-freeLatexExaminationGloves510K # K071060	Pt. Maja AgungLatexindoPowder-freeLatexExaminationGloves510K # K081488	SubstantialEquivalence(SE)
Product Code	LYY	LYY	LYY
Intended Use	A powder freepatientexaminationglove is adisposable deviceintended formedical purposesthat is worn onthe examinershand or finger topreventcontaminationbetween patientand examiner.	A powder freepatient examinationglove is adisposable deviceintended formedical purposesthat is worn on theexaminers hand orfinger to preventcontaminationbetween patient andexaminer.	A powder freepatientexamination gloveis a disposabledevice intended formedical purposesthat is worn on theexaminers hand orfinger to preventcontaminationbetween patientand examiner.	SE
Width (sizemedium)	95 +/- 5 mm	90-97mm	95 +/- 5 mm	SE
Overall length	Min 240 mm	241 mm	240 mm	SE
Palm thickness	Min 0.08 mm	0.10 mm	0.10 mm

{2}------------------------------------------------

Finger thickness	Min 0.08 mm	0.13 mm	0.10 mm
Tensile strength pre aging min	Min 18 Mpa	27 mpa	18 mpa
Tensile strength after aging min	Min 14 Mpa	25.8	14 mpa	Minor difference
Ultimate elongation pre aging min	Min 650%	830%	650%
Ultimate elongation after aging min	Min 500%	730%	500%
Meets Biocompatibility	YES	Yes	Yes	SE
Duration of bio-compatibility	Except product change
Skin irritation test	Pass	Pass	Pass	SE
Dermal sensitization	Pass	Pass	Pass
AQL	1.5%	2.5%	NA	SE
Residual Powder Content	Max 2.0mg/glove	1.1 mg/glove	NA	SE
Residual Protein Level	< 50 $ μ $ g/g	< 50 $ μ $ g/ dm2	NA	SE

12. Summary of Testing:

Test	Results
a. Dermal Sensitization Test	Passes
b. Primary Skin irritation	Passes
c. Iodine Test	Passes
d. Tensile strength	Gloves meets the requirements ofASTM D3578-05.

The standards used by Koon Seng Sdn. Bhd. to determine substantial equivalence is based on ASTM D3578-05a. All testing meets requirements for physical specifications and dimensions conducted on gloves, Inspection level S-2, AQL 4.0, pinholes at AQL 2.5

We do not claim our gloves to be hypoallergenic.

13. Conclusion:

'KS-CARE' Powder Free Polymer Coated Latex Examination Glove (with Protein Content labeling) performance was equivalent to any other conventional method evaluated. Our evaluation concluded that our device raises no new issues of Safety and effectiveness.

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle's head in profile, with three swooping lines representing the feathers. The eagle faces to the right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

DEC - 2 2009

Koon Seng Sdn. Bhd. C/O Mr. Jay Y. Kogoma Responsible Third Party Official Intertek Testing Services NA, Incorporated 2307 East Aurora Road, Unit B7 Twinsburg, Ohio 44087

Re: K093375

Trade/Device Name: Powder Free Polymer Coated Latex Examination Glove with Protein Content Labeling Claim (50 Micrograms or Less) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: November 17, 2009 Received: November 18, 2009

Dear Mr. Kogoma:

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 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.

{4}------------------------------------------------

Page 2- Mr. Kogoma

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance,

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Anthony D. Austin Jr.

Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

EXHIBIT #3

Indications for Use

510(k) Number (if known): K_09 3375

Applicant: Koon Seng Sdn. Bhd.

Device Name: Powder Free Polymer Coated Latex Examination Glove with Protein Content Labeling Claim (50 Micrograms or Less)

Indications for Usc:

A powder free patient examination glove is a disposable device intended for medical purposes that is worn on the examiners hand or finger to prevent contamination between patient and examiner.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use X (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elizabeth F. Qawaine-Willien Z

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

0 93375 510(k) Number:

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.