The Non-Sterile, Latex, Powder-Free Patient Examination Gloves (Multicolored), with Protein Labeling Claim (50 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 mecting all the requirements of ASTM-D3578-01aE2 Standard Specification for Latex Examination Glowes for Medical Application.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria (ASTM D3578-01aE2 or FDA/Internal Requirements)	Reported Device Performance (SGMP / Lot# 4144)
Dimension
X-Small Width	70 mm +/- 10 mm	70 – 80 mm
Small Width	80 mm +/- 10 mm	80 – 85 mm
Medium Width	95 mm +/- 10 mm	90 – 97 mm
Large Width	111 mm +/- 10 mm	105 - 111 mm
Length (all sizes)	230 mm minimum	242 mm
Thickness - Finger	0.08 mm min	0.13 mm min
Thickness - Palm	0.08 mm min	0.1 mm min
Physical Properties
Ten. Strength Before Aging	18.0 Mpa	X-Small: 23.5 Mpa; Small: 26.8 Mpa; Medium: 22.5 Mpa; Large: 29.2 Mpa
Ult. Elong. Before Aging	650 %	X-Small: 890 %; Small: 800 %; Medium: 850 %; Large: 870 %
Ten. Strength After Aging	14.0 Mpa	X-Small: 22.8 Mpa; Small: 27.5 Mpa; Medium: 28.3 Mpa; Large: 26.8 Mpa
Ult. Elong. After Aging	500 %	X-Small: 780 %; Small: 820 %; Medium: 750 %; Large: 820 %
Water Tight Test	ASTM D3578-00aE2 requirements for latex exam gloves of 2.5% AQL (Acceptance Quality Limit)	Un-aged (X-Small: 0, Small: 1, Medium: 2, Large: 0 leaks); Aged (X-Small: 0, Small: 1, Medium: 1, Large: 2 leaks) - All within 2.5% AQL
Biocompatibility	Passed tests for examination gloves (as per APPENDIX K)	Passed (results as per APPENDIX K)
Residual Powder Content	FDA Requirement: 2 mg/glove max (ASTM D 6124-00)	Range: 0.4 - 1.0 mg/glove; Mean: 0.8 mg/glove
Presence of Cornstarch	Negative	Negative
Residual Protein Level	<50 µg/dm²	<50 µg/dm² (implied by the conclusion and regulatory approval)

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

Sample Size (Water Tight Test): 125 pieces for each size (X-Small, Small, Medium, Large) for both un-aged and aged gloves. This totals 125 * 4 * 2 = 1000 gloves tested for water tightness.
Sample Size (Physical Properties): Not explicitly stated how many gloves were tested for each physical property (Tensile Strength, Ultimate Elongation) for each size, but the results are reported for each size on "Lot# 4144."
Data Provenance: The data is retrospective and comes from internal testing conducted by SGMP Company Limited, a company located in Thailand.

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

Not applicable to this type of device (patient examination gloves). The testing involves objective, measurable physical and chemical properties rather than expert interpretation.

4. Adjudication Method for the Test Set

Not applicable. The tests are objective measurements (e.g., dimension, tensile strength, water leak count, chemical analysis).

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 medical device (examination glove), not an AI diagnostic or interpretive tool. There are no "human readers" interpreting data.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is not an algorithm-based device.

7. The Type of Ground Truth Used

The ground truth used for this device is based on established industry standards and regulatory requirements, specifically:

ASTM D3578-01aE2 (Standard Specification for Latex Examination Gloves for Medical Application) for dimensions and physical properties.
ASTM D3578-00aE2 (a previous version of the same standard) for physical properties and water-tightness (2.5% AQL).
FDA specified 1,000 ml water leak test for water tightness.
ASTM D 6124-00 for Residual Powder Content.
FDA requirements for powder content and protein labeling claims.
Biocompatibility test standards (referenced in APPENDIX K).

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not a machine learning model that requires a training set.

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

Not applicable, as there is no training set for this device.

Summary

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Image /page/0/Picture/1 description: The image shows a handwritten string of characters, "K052016". The characters are written in a dark ink on a white background. The characters are all connected, and the string is slightly curved.

APPENDIX L

510(k) SUMMARY SUMMARY OF THE SAFETY AND EFFECTIVENESS FOR POWDER-FREE MULTICOLOR LATEX EXAMINATION GLOVES

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

Submitted By: Tucker & Associates Official Correspondent for SGMP Co Ltd Janna P. Tucker, President - CEO 198 Avenue de la D'emcrald, Sparks, NV 89434-9550 Phone No : 775-342-2612 Fax No : 775-342-2613 E-mail: Tuckerjan@aol.com
Equivalent Predicate Device: POWDER FREE BLUE LATEX EXAM GLOVES which was granted a 510(k) # K011377 and POWDER-FREE PINK LATEX EXAM GLOVES which was also granted a 510 (k) # K011371 as shown in APPENDIX M

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

Device Information:

Trade Name - NON-STERILF POWDER FREE MULTICOLOR LATEX EXAMINATION GLOVES

Common Name - Exam gloves

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

Classification Information - Class I Latex patient examination glove 80LYY, powder free and meeting all the requirements of ASTM-D3578-01aE2 Standard Specification for U.atex Examination Gloves for Medical Application.

Device Description:

Class I latex patient examination gloves 80LYY, powder free and mecting all the requirements of ASTM-D3578-01aE2 Standard Specification for Latex Examination Glowes 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 D3578-01aE2	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	242 mm
Thickness - Finger	0.08 mm min	0.13 mm min
Palm	0.08 mm min	0.1 mm min

2. Physical Properties (ASTM-D3578-00aE2 Standard Specification for Latex Exam Gloves) on Lot# 4144

	TENSILE STRENGTH		ULTIMATE ELONGATION
	ASTM-D3578-00aE2	SGMP	ASTM-D378-00aE2	SGMP
	Mpa	Mpa	%	%
Before Aging	18.0		650
X-Small		23.5		890
Small		26.8		800
Medium		22.5		850
Large		29.2		870
After Aging	14.0		500
X-Small		22.8		780
Small		27.5		820
Medium		28.3		750
Large		26.8		820

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3. Water Tight Test

BATCH #	SIZE	SAMPLE SIZE	LEAK STATUS	NUMBERLEAKED
UN-AGED4144	X-Small	125	No	0
4144	Small	125	Yes	1
4144	Medium	125	Yes	2
4144	Large	125	No	0
AGED4144	X-Small	125	No	0
4144	Small	125	Yes	1
4144	Medium	125	Yes	1
4144	Large	125	Yes	2

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

The above figures are within the ASTM D3578-00aE2 requirements for latex exam gloves of 2.5% AQL.

Biocompatibility 4.

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

5. Total Residual Powder Content & Presence of Cornstarch

TEST	FDAREQUIREMENT	INTERNAL SGMP's
Residual Powder Content(ASTM D 6124-00)	2 mg/glove max	Ranger: 0.4 - 1.0 mg/gloveMean: 0.8 mg/glove
Presence of Cornstarch	Negative	Negative

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6. Residual Protein Level.

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Conclusion:-

The data presented indicate that the Non-sterile Powder Free Multicolor Latex Examination Gloves.

1. meets/exceeds ASTM- D3578-00aE2 Standard Specifications For Latex Examination Glove,
1. meets FDA pinhole requirements,
1. meets FDA claim criterion of a powder free glove.
1. meets the protein labelling claims level at <50 µg/ dm2

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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health and Human Services, USA. The seal features an abstract eagle design with three stylized lines representing the eagle's body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle emblem.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 0 1 2005

SGMP Company Limited C/O Janna P. Tucker Tucker & Associates 198 Avenue De La D'Emerald Sparks, Nevada 89434

Re: K052016

Trade/Device Name: Non-Sterile, Latex, Powder-Free Patient Examination Glove (Multicolored), with Protein Labeling Claim (50 Micrograms or Less) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: August 9, 2005 Received: August 25, 2005

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 ( vour 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 moan that I Drima muse statutes and regulations administered by other Federal agencies. or the Fer of all the Act's requirements, including, but not limited to: registration r od intilety (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice und listing (21 er read vo 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) I mo reter notification. The FDA finding of substantial equivalence of your device to a premaired 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), 11 you desire specific at 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 maj overs 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,

Syndie Y. Michie Dmd.

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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Indications for Use

Applicant: SGMP Company Ltd.

510(k) Number (if known): K052016

Device Name: _Non-Sterile, Latex, Powder-Free Patient Examination Gloves (Multicolored), with Protein Labeling Claim (50 Micrograms or less)

Indications For Use:

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

Over-The-Counter Use (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)

Sheila f. Murphy, M.D. 8/31/15
(Division Sign-Off)

Division of Anesthesiology. General Hospital Infection Control, Dental Devices

510(k) Number: K052016

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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.