The Non-Sterile, Powder-Free, Latex Examination Gloves with Lanolin and Vitamin E Coating, Green and with Protein Labeling Claim (50 micrograms or less total water extractable protein per gram of glove), is a disposable device intended for Medical Purposes that is worn on the examiners hand to prevent contamination between patient and examiner.

Device Description

Non-Sterile, Powder-Free, Latex Examination Gloves with Lanolin and Vitamin E Coating, Green and with Protein Labeling Claim

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the "Non-Sterile, Powder-Free, Latex Examination Gloves with Lanolin and Vitamin E Coating, Green and with Protein Labeling Claim," based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Criteria	Acceptance Criteria (Minimum/Maximum)	Reported Device Performance
Material	Latex	Latex
Cuff	Beaded	Beaded
Powder Residue	2mg/glove maximum	N/A (implied compliance)
Inspection Level: Dimensions	S-2, AQL 4.0	N/A (implied compliance)
Inspection Level: Physical Properties	S-2, AQL 4.0	N/A (implied compliance)
Inspection Level: Water Tight Test 1000ml	G-1, AQL 1.5	N/A (implied compliance)
Inspection Level: Visual Major Defects	G-1, AQL 1.5	N/A (implied compliance)
Inspection Level: Visual Minor Defects	G-1, AQL 2.5	N/A (implied compliance)
Overall Length	240 mm minimum	240 mm minimum
Width (medium glove)	95 mm minimum	95 mm minimum
Thickness	0.08 mm minimum	0.08 mm minimum
Tensile Strength (Before Aging)	18.0 Mpa minimum	18.0 Mpa minimum
Ultimate Elongation (Before Aging)	650% minimum	650% minimum
Tensile Strength (After Aging)	14.0 Mpa minimum	14.0 Mpa minimum
Ultimate Elongation (After Aging)	500% minimum	500% minimum
Special Properties	Lanolin and Vitamin E inner coating	Lanolin and Vitamin E inner coating
Protein Labeling Claim Level	< 50ug/g	< 50ug/g

Note: The reported device performance often states "minimum" or "maximum" values that align with the acceptance criteria, suggesting the device met or exceeded these thresholds. For inspection parameters, the text states "In compliance with ASTM D3578-10.ISO 2859-1:1999" and lists the AQLs, implying the device met these standards through the specified inspection levels.

The provided text describes a 510(k) premarket notification for a medical device (examination gloves). This type of submission focuses on demonstrating substantial equivalence to a previously legally marketed device (predicate device), rather than a detailed clinical study proving efficacy in the same way a new drug or novel high-risk device might. Therefore, many of the typical questions for a "study that proves the device meets acceptance criteria" are not directly applicable or are answered implicitly through the regulatory framework.

Here's a breakdown of the other requested information based on the provided text:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: The document does not specify a distinct "test set" sample size in terms of the number of gloves tested for each criterion. Instead, it refers to industry standards (ASTM D3578-10, ISO 2859-1:1999) and inspection levels (S-2, G-1) with Acceptance Quality Limits (AQLs). These standards inherently define the sampling plans used for quality control testing.
Data Provenance: The manufacturer is "UG Global Resources Sdn Bhd 181 Floor No. 18 Jalan Dato' Abd Rahman 70000 Seremban Malaysia." This indicates the testing and data likely originated from Malaysia. The study is prospective in nature, as it involves testing the manufactured gloves to ensure they meet the defined specifications before market release.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable to this type of device and submission. The "ground truth" for examination gloves is defined by adherence to established engineering and material science standards (ASTM, ISO), manufacturing quality control processes, and biocompatibility testing, not by expert consensus on clinical interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This question is not applicable. Adjudication methods like 2+1 or 3+1 are used for interpreting subjective data, typically in clinical trials involving image analysis or symptom assessment. The tests performed on these gloves are objective physical and chemical measurements.

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

This question is not applicable. MRMC studies are used for evaluating diagnostic devices, particularly those involving human interpretation (e.g., radiology AI). This device is an examination glove, which does not involve "readers" or "AI assistance."

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

This question is not applicable. This device is a physical product, not an algorithm, and does not involve AI or standalone algorithmic performance.

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

The "ground truth" for the performance of these gloves is based on:
- Established Industry Standards: Primarily ASTM D3578-10 for physical properties and ISO 2859-1:1999 for quality assurance.
- FDA 1000 ml water test: A specific regulatory test for watertight integrity.
- Biocompatibility Test Results: To ensure safety in contact with skin.
- Residual Powder Contents tests: To verify "powder-free" claim.
- Protein Labeling Claim Level: Chemical testing to quantify protein levels.

8. The sample size for the training set

This question is not applicable. "Training sets" are relevant for machine learning algorithms. For manufactured goods like gloves, there isn't a "training set" in this context. The manufacturing process is designed and monitored to consistently produce gloves meeting specifications, and ongoing quality control (using the stated inspection levels and AQLs) ensures this.

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

This question is not applicable as there is no "training set" in the context of this device. The "ground truth" for acceptable glove performance is established by the specifications themselves, derived from regulatory requirements and industry standards.

Summary

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SUMMARY PREMARKET 510(k) NOTIFICATION Non-Sterile, Powder-Free, Latex Examination Gloves with Lanolin and Vitamin E Coating, Green and with Protein Labeling Claim

KIII604

JUN - 8 200

Submission Applicant -

UG Global Resources Sdn Bhd 181 Floor No. 18 Jalan Dato' Abd Rahman 70000 Seremban Malaysia

Official Correspondent -

Kenneth J. Stanton 1565 Sunflower Avenue Costa Mesa, Ca 92626 Tel: (714)444-2248 Fax: (714)444-2271

Submitted: November 16, 2011

Description of the Device: Non-Sterile, Powder-Free, Latex Examination Gloves with Lanolin and Vitamin E Coating, Green and with Protein Labeling Claim

Trade Name: Lano-E

Common Name: Examination Gloves A. Classification Name: Patient Examination Glove (per 21 CFR 880.6251) Class 1: Powder-Free Latex examination glove 80LYY that meets all of the requirements of ASTM D3578-10. Predicative Devices: Latex Powder-Free Examination Gloves

Intended Use of the Device: A 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 the patient and the examiner.

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SUMMARY PREMARKET 510(k) NOTIFICATION for - Non-Sterile, Powder-Free, Latex Examination Gloves with Lanolin and Vitamin E Coating, Green and with Protein Labeling Claim

1011604

Summary of Technological Characteristics:

Material: Latex Cuff: Beaded Powder Residue: Maximum 2mg/glove In compliance with ASTM D3578-10.ISO 2859-1:1999. Quality Assurance: manufactured under ISO9001:2000 and ISO 13485

Inspection Parameters:

Criteria	Inspection Level	AQL
Dimensions	S-2	4.0
Physical Properties	S-2	4.0
Water Tight Test 1000ml	G-1	1.5
Visual Major Defects	G-1	1.5
Visual Minor Defects	G-1	2.5

Physical Properties:

Dimensions:
Overall Length:	240 mm minimum
Width:	95 mm minimum (for medium glove)
Thickness:	.08mm minimum

BEFORE AGING

Tensile Strength: 18.0. Mpa minimum Ultimate Elongation:650% minimum

AFTER AGING 14.0 Mpa minimum

500% minimum

Special Properties: Lanolin and Vitamin E inner coating

Packaging: 100 pcs per dispenser box, 10 boxes per case, 1,000 gloves per case

Sizes: XS — XL

Conclusion: The Non-Sterile, Powder-Free, Latex Examination Gloves with Lanolin and Vitamin E Coating, Green and with Protein Labeling Claim meets the physical property requirements of ASTM D 3578-10, the FDA 1000 ml water test both before and after aging, and the Protein Labeling Claim Level at <50ug/g. This product is as safe, as effective, and performs as well or better than the legally marketed 510 #K013163. It has been supported by results of Biocompatibility Tests, Residual Powder Contents tests, Physical Property Tests and the 1000ml Water Tight Test.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized eagle or bird-like symbol with three curved lines representing its wings or body.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

JUN - 8 2012

UG Global Resources, SDN BHD % Mr. Kenneth J. Stanton President. UG Healthcare (USA) Incorporated 1565 Sunflower Ave. Costa Mesa, California 92626

Re: K11604

Trade/Device Name: Non-Sterile, Powder-Free, Latex Examination Gloves with Lanolin and Vitamin E Coating, Green and with Protein Labeling Claim Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: May 29, 2012 Received: May 29, 2012

Dear Mr. Stanton:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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. . . . . . . . . .

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Dear Mr. Stanton

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/MedicalDevices/Safety/ReportaProblem/default.htm 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerelv vours.

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

Enclosure

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3.0 Indications for Use:

510K 111604

Device Name: Non-Sterile, Powder-Free, Latex Examination Gloves with Lanolin and Vitamin E Coating, Green and with Protein Labeling Claim

Indications for Use - The Non-Sterile, Powder-Free, Latex Examination Gloves with Lanolin and Vitamin E Coating, Green and with Protein Labeling Claim (50 micrograms or less total water extractable protein per gram of glove), is a disposable device intended for Medical Purposes that is worn on the examiners hand to prevent contamination between patient and examiner.

Prescription Use (Part 21 CFR 801 Subpart D) and/or Over-The-Counter Use (Part 21 CFR 801 Subpart C)

(Please do not write below this line-continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

E.L.L. F. Currie Well

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

510(k) Number: K 111 60.4

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.