The Non-Sterile Powdered Pink Latex Examination Gloves with Cherry Flavour and with Protein Labeling claims (200 Micrograms or less) 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

Class I latex patient examination gloves 80LYY, powder free and meeting all the requirements of ASTM-D3578-05 Standard Specification for Latex Examination Gloves for Medical Application.

AI/ML Overview

The provided text describes the acceptance criteria and the study conducted for "Non-Sterile, Powdered Pink Latex Examination Gloves with Cherry Flavour and with Protein Labeling Claims (200 Micrograms or Less)."

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Metric (ASTM D3578-05)	Reported Device Performance (SGMP)	Pass/Fail
Dimension
X-Small (Width)	70 mm +/- 10 mm	70 - 80 mm	Pass
Small (Width)	80 mm +/- 10 mm	80 - 85 mm	Pass
Medium (Width)	95 mm +/- 10 mm	90 - 97 mm	Pass
Large (Width)	111 mm +/- 10 mm	105 - 111 mm	Pass
Length (all sizes)	230 mm minimum	240 mm	Pass
Thickness - Finger	0.08 mm min	0.13 mm min	Pass
Thickness - Palm	0.08 mm min	0.10 mm min	Pass
Physical Properties
Tensile Strength (Mpa)
Before Aging	18.0 Mpa	X-Small: 23.5 MpaSmall: 28.8 MpaMedium: 22.7 MpaLarge: 25.5 Mpa	Pass
After Aging	14.0 Mpa	X-Small: 21.8 MpaSmall: 25.5 MpaMedium: 22.3 MpaLarge: 23.8 Mpa	Pass
Ultimate Elongation (%)
Before Aging	650 %	X-Small: 780 %Small: 920 %Medium: 835 %Large: 810 %	Pass
After Aging	500 %	X-Small: 740 %Small: 850 %Medium: 780 %Large: 830 %	Pass
Water Tight Test	2.5% AQL (max. 25 leaky gloves per 1000)	UN-AGED: 2-2-1-2 leaky gloves (total 7/500)AGED: 0-3-2-1 leaky gloves (total 6/500)	Pass
Total Residual Powder Content	10 mg/dm² max (ASTM D 6124-06)	Range: 5.2 - 8.5 mg/dm²Mean: 7.5 mg/dm²	Pass
Residual Protein Level	< 200 µg/dm² (ASTM D 5712-99)	< 200 µg/dm²	Pass
Biocompatibility	General requirements for examination gloves	Passed tests (as per Appendix H)	Pass

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

Sample Size for Water Tight Test: 125 pieces for each glove size (X-Small, Small, Medium, Large) for both un-aged and aged conditions. This totals 1000 gloves tested (125 * 4 sizes * 2 conditions).
Sample Size for Physical Properties: Not explicitly stated but implied to be sufficient for testing tensile strength and ultimate elongation for each size, both before and after aging.
Sample Size for Total Residual Powder Content: Not explicitly stated, but a range and mean are provided, suggesting multiple measurements.
Sample Size for Residual Protein Level: Not explicitly stated, but the "Claimed Level" implies testing was performed.
Data Provenance: The report is submitted by SGMP Company Limited, located in Thailand. The testing standards (ASTM) are international. The data is retrospective, as it's presented as the results of completed tests.

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

This type of information is not applicable to the evaluation of medical gloves. The "ground truth" for glove performance is established by objective, standardized laboratory tests according to ASTM (American Society for Testing and Materials) standards, such as D3578-05 for latex examination gloves, D6124-06 for residual powder, and D5712-99 for protein level. There are no human experts "establishing ground truth" in the way one would for diagnostic imaging.

4. Adjudication Method for the Test Set

Not applicable. Physical and chemical properties of gloves are measured using standardized test methods, not through 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

Not applicable. This is a submission for a medical device (examination gloves), not an artificial intelligence (AI) diagnostic or assistive technology. Therefore, no MRMC or AI-related effectiveness study was performed.

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

Not applicable. This device is not an algorithm or AI system.

7. The Type of Ground Truth Used

The ground truth used for evaluating the gloves' performance is based on objective, standardized test methods and specifications outlined in:

ASTM D3578-05 Standard Specification for Latex Examination Gloves for Medical Application (for dimensions, physical properties, and water-tightness AQL).
ASTM D 6124-06 for Total Residual Powder Content.
ASTM D 5712-99 for Residual Protein Level.
Biocompatibility tests (details in Appendix H, not provided, but implying standard in vitro/in vivo biocompatibility assessments).

8. The Sample Size for the Training Set

Not applicable. There is no machine learning or AI component requiring a "training set" for this medical device.

9. How the Ground Truth for the Training Set was Established

Not applicable, as no training set was used.

Summary

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APPENDIX I

K072403

510(k) SUMMARY

SUMMARY OF THE SAFETY AND EFFECTIVENESS FOR POWDERED PINK LATEX EXAMINATION GLOVES WITH CHERRY FLAVOUR AND WITH PROTEIN LABELING CLAIMS (200 MICROGRAMS OR LESS)

Submitted For : SGMP Company Limited, 181 Moo 6, Tambol Kampaengpetch, Rattaphum, Songkhla 90180, Thailand.

Submitted By: Tucker & Associates Official Correspondent for SGMP Co Ltd Janna P. Tucker, President - CEO 198 Avenue de la D'emerald, Sparks, NV 89434-9550 Phone No : 775-342-2612 Fax No : 775-342-2613 E-mail: Tuckerjan@aol.com

Equivalent Predicate Device: POWDERED PINK LATEX EXAM GLOVES which was granted a 510(k) # K000671

This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.

Device Information:

Trade Name - Non-Sterile, Powdered Pink Latex Examination Gloves with Cherry Flavour and with protein labeling claims (200 Micrograms or less)

Common Name - Exam gloves

Classification Name - Patient examination glove (per 21 CFR 880.6250)

Classification Information - Class I Latex patient examination glove 80LYY, powdered and meeting all the requirements of ASTM-D3578-05 Standard Specification for Latex Examination Gloves for Medical Application.

Device Description:

Class I latex patient examination gloves 80LYY, powder free and meeting all the requirements of ASTM-D3578-05 Standard Specification for Latex Examination Gloves for Medical Application.

Intended Use of Device:

A medical glove to be worn on the hand of the health care and similar personnel to prevent contamination between health care personnel and patient.

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Technological Characteristics of Device:

1. Dimension

DIMENSION	ASTM D3578-05	SGMP
X-Small	70 mm +/- 10 mm	70 - 80 mm
Small	80 mm +/- 10 mm	80 - 85 mm
Medium	95 mm +/- 10 mm	90 - 97 mm
Large	111 mm +/- 10 mm	105 - 111 mm
Length	230 mm minimumfor all sizes	240 mm
Thickness - Finger	0.08 mm min	0.13 mm min
Palm	0.08 mm min	0.10 mm min

1. Physical Properties (ASTM-D3578-05 Standard Specification for Latex Exam Gloves) on Lot# 7037 ి.

	TENSILE STRENGTH		ULTIMATE ELONGATION
	ASTM-D3578-05	SGMP	ASTM-D3578-05	SGMP
	Mpa	Mpa	%	%
Before Aging	18.0		650
X-Small		23.5		780
Small		28.8		920
Medium		22.7		835
Large		25.5		810
After Aging	14.0		500
X-Small		21.8		740
Small		25.5		850
Medium		22.3		780
Large		23.8		830

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3. Water Tight Test

Batch #	Size	Sample Size	Leak Status	Number Leaked
UN-AGED
7037	X-Small	125	Yes	2
7037	Small	125	Yes	2
7037	Medium	125	Yes	1
7037	Large	125	Yes	2
AGED
7037	X-Small	125	No	0
7037	Small	125	Yes	3
7037	Medium	125	Yes	2
7037	Large	125	Yes	1

Using the FDA specified 1,000 ml water leak test, 125 pieces of each size of the gloves were tested and our results are as given below:

The above figures are within the ASTM D3578-05 requirements for latex exam gloves of 2.5% AQL.

Biocompatibility 4.

The bio-compatibility test results are as per attached in APPENDIX H and show that the gloves passed the tests for examination gloves.

5. Total Residual Powder Content & Presence of Cornstarch

Test	FDA Requirement	Internal SGMP'S
Residual Powder Content(ASTM D 6124-06)	10 mg/ dm2 max	Range : 5.2 - 8.5 mg/ dm2Mean : 7.5 mg / dm2

6. Residual Protein Level.

Test	FDA Allowable level	Claimed Level
ASTM D 5712-99	< 200 µg/ dm²	< 200 µg/ dm²

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Conclusion :-

The data presented indicate that the Non-Sterile, Powdered Pink Latex Examination Gloves with Cherry Flavour and with protein labeling claims (200 Micrograms or less)

meets/exceeds ASTM- D3578-05 Standard Specifications For Latex Examination Glove,

meets FDA pinhole requirements, 2.

meets the protein labeling claims level at <200 ug/ dm2

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a human figure embracing or supporting another, representing the department's mission of protecting and promoting the health and well-being of Americans.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 7 2008

SGMP Company Limited C/O Ms. Janna P. Tucker Official Correspondent Tucker & Associates 198 Avenue de la D'emerald Sparks, Nevada 89434-9550

Re: K072403

Trade/Device Name: Non-Sterile, Powdered Pink Latex Examination Gloves with Cherry Flavour and with Protein Labeling Claims (200 Micrograms or Less) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY

Dated: March 11, 2008 Received: March 13, 2008

Dear Ms. Tucker:

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 - Ms. Tucker

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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Qur

Chiu Lin, Ph.D. 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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INDICATION FOR USE STATEMENT

Applicant : SGMP Company Limited

510K NUMBER: K072 403

Device Name : Non-Sterile, Powdered Pink Latex Examination Gloves with Cherry Flavour and with Protein Labeling claims (200 Micrograms or less)

Indication For Use :

Prescription Use .. (Part 21 CFR 801.Subpart D)

AND / OR

Over-The-Counter........................
21 CFR 801 Subpart C

Concurrence of CDRH , Office of Device Evaluation (ODE)

Shule R. Murphy, 10
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K022403

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.