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

Device Description

Class I latex patient examination glove, 80LYY, powder free And meeting all the requirements of ASTM D-3578-01aE2, Standard Specification for Latex Examination Gloves for Medical Application.

AI/ML Overview

The provided document does not describe an AI medical device. It pertains to a Non-Sterile Powder-Free Green Latex Examination Gloves with or without Sour Apple or Peppermint Scenting Plus a Protein Labeling Claim (<50uG/G).

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth, expert involvement, and AI performance metrics is not applicable in the context of an AI device.

However, I can extract the acceptance criteria and performance of the latex examination gloves as presented in the document:

1. Table of Acceptance Criteria and Reported Device Performance for Latex Examination Gloves

Test	Acceptance Criteria (ASTM D3578-01aE2 or FDA)	Reported Device Performance (SGMP)
Dimension
Width
X-Small	70 mm +/- 10 mm	70 - 75 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 minimum for all sizes	242 mm
Thickness
Finger	0.08 mm min	0.08 mm min
Palm	0.08 mm min	0.08 mm min
Physical Properties (Tensile Strength)
Before Aging	14.0 Mpa	X-Small: 26.0 MpaSmall: 27.3 MpaMedium: 27.9 MpaLarge: 27.4 Mpa
After Aging	14.0 Mpa	X-Small: 24.5 MpaSmall: 28.5 MpaMedium: 28.0 MpaLarge: 21.5 Mpa
Physical Properties (Ultimate Elongation)
Before Aging	700 %	X-Small: 990 %Small: 880 %Medium: 860 %Large: 870 %
After Aging	500 %	X-Small: 950 %Small: 950 %Medium: 950 %Large: 920 %
Water Tight Test (Leak Status)	2.5% AQL (acceptable quality level) for leaks (implied by meeting ASTM D3578-01aE2)	Un-aged: X-Small: 1 leak (0.8%)Small: 0 leaks (0%)Medium: 0 leaks (0%)Large: 1 leak (0.8%)Aged: X-Small: 0 leaks (0%)Small: 0 leaks (0%)Medium: 1 leak (0.8%)Large: 1 leak (0.8%)All reported leaks are within 2.5% AQL.
Residual Powder Content	2 mg/glove max	Range: 0.5-0.8 mg/gloveMean: 0.63 mg/glove
Presence of Cornstarch	Negative	Negative
Residual Protein Level (ASTM D 5712-99)	< 50 µg/g	< 50 µg/g
Biocompatibility	Gloved passed tests for examination gloves (as per APPENDIX L)	Passed

Regarding the other points, as this is not an AI device, the following are not applicable:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
For the physical and watertight tests, the "test set" consisted of various glove sizes from Lot# 0320.

Dimensions, Physical Properties, Residual Powder Content, Presence of Cornstarch, Residual Protein Level: Data is reported for Lot# 0320. The sample sizes are not explicitly stated for all tests, but for the watertight test, 125 pieces of each size were tested for both un-aged and aged conditions. The data provenance is not specified, but it implies internal testing by SGMP Company Ltd.

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):
Not applicable. Ground truth for glove performance is established by standardized testing protocols (e.g., ASTM standards, FDA water leak test) not by expert consensus in a medical diagnostic sense.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable for this type of device. Performance is determined by objective measurements against established standards.

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 not an AI device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for the glove performance is based on established engineering and medical device standards (e.g., ASTM D3578-01aE2, FDA water leak test, ASTM D 6124-01, ASTM D 5712-99) and objective measurements.

8. The sample size for the training set:
Not applicable. This is not an AI device, and thus does not have a "training set."

9. How the ground truth for the training set was established:
Not applicable. This is not an AI device.

Summary

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K032293

APPENDIX M

510(k) SUMMARY

NON-STERILE POWDER-FREE GREEN LATEX EXAMINATION GLOVES WITH OR WITHOUT SOUR APPLE OR PEPPERMINT SCENTING PLUS A PRQTEIN LABELING CLAIM (<50uG/G) (Contains 50 grams or less of water extractable protein per gram of glove)

Submitted For: SGMP COMPANY LTD.

TUCKER & ASSOCIATES Submitted By: Official Correspondent for SGMP COMPANY LTD. JANNA P. TUCKER, President - CEO 198 Avenue de la D'emerald Sparks, NV 89434-9550 775-342-2612 Phone: 775-342-2613 Fax: E-Mail: Tuckerjan@aol.com

Equivalent Predicate Device: POWDER FREE PURPLE LATEX EXAM GLOVES WITH AND WITHOUT GRAPE SCENTING which was approved for marketing as K011370.

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

Device Information:

Trade Name:	NON-STERILE POWDER FREE GREEN LATEX EXAMGLOVES WITH/WITHOUT SOUR APPLE/PEPPERMINTSCENTING AND WITH PROTEIN LABELING (<50uG/G)
Common Name:	Latex Exam Gloves.
Classification Name:	Patient Examination Glove, Latex.
Classification Information& Device Description:	Class I latex patient examination glove, 80LYY, powder freeAnd meeting all the requirements of ASTM D-3578-01aE2,Standard Specification for Latex Examination Gloves forMedical Application.
Intended Use of Device:	A medical glove to be worn on the hand of the health care andsimilar personnel to prevent contamination between healthcare personnel and the patient.

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Technological Characteristics of Device:

DIMENSION		ASTM D3578-01aE2	SGMP
X-Small		70 mm +/- 10 mm	70 - 75 mm
Small		80 mm +/- 10mm	80 - 85 mm
Medium		95 mm +/- 10mm	90 - 97 mm
Large		111mm +/- 10mm	105 - 111 mm
Length		230 mm minimumfor all sizes	242mm
Thickness -	Finger	0.08mm min	0.08 mm min
	Palm	0.08mm min	0.08 mm min

1. Dimension

2. Physical Properties (ASTM-D3578-01aE2 Standard Specification for Latex Exam Gloves) on Lot# 0320

	TENSILE STRENGTH		ULTIMATE ELONGATION
	ASTM-D3578-01aE2	SGMP	ASTM-D3578-01aE2	SGMP
Before AgingX-SmallSmallMediumLarge	Mpa14.0	Mpa26.027.327.927.4	%700	%990880860870
After AgingX-SmallSmallMediumLarge	14.0	24.528.528.021.5	500	%950950950920

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3. Water Tight Test

BATCH #	SIZE	SAMPLE SIZE	LEAK STATUS	NUMBERLEAKED
UN-AGED
0320	X-Small	125	Yes	1
0320	Small	125	No	0
0320	Medium	125	No	0
0320	Large	125	Yes	1
AGED
0320	X-Small	125	No	0
0320	Small	125	No	0
0320	Medium	125	Yes	1
0320	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 D3578-01aE2 requirements for latex exam gloves of 2.5% AQL.

Biocompatibility 4.

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

5. Total Residual Powder Content & Presence of Cornstarch

TESTS	FDA INTERNALREQUIREMENT	SGMP's
Residual PowderContent(ASTM D 6124-01)	2 mg glove max	Range: 0.5-0.8mg gloveMean : 0.63 mg glove
Presence of Cornstarch	Negative	Negative

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6. Residual Protein Level

TESTS	FDA ALLOWABLE LEVEL	CLAIMED LEVEL
ASTM D 5712-99	< 50 µg/g	< 50 µg/g

Conclusion:-

The data presented indicate that the Non-sterile Powder Free Green latex examination glove with Sour Apple/Peppermint Scenting

Standard Specifications For Latex Examination 1. meets/exceeds ASTM- D3578-01aE2 Glove,
1. meets FDA pinhole requirements,
1. meets FDA claim criterion of a powder free glove.
1. meets the protein labeling claim level at <50 µg/g.

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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 stylized eagle with three stripes representing the department's mission to promote health, well-being, and human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 8 2003

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

Re: K032293

Trade/Device Name: Non-Sterile Powder Free Green Latex Exam Latex Examination Gloves with or without Sour Apple or Peppermint Scenting Plus a Protein Labeling Claim (<50uG/G) Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: July 23, 2003 Received: July 25, 2003

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 narketed 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 (301) 594-4618. 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/dsma/dsmamain.html

Sincerely yours,

Susan Runse

Susan Runner, DDS, MA Interim 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

K032293 510K NUMBER :

Device Name : Non-sterile Powder Free Green Latex Examination Gloves with on FINS 5D microgram orless of Total Vealer expression Indication For Use :

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

Qhin S. Lim

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

510(k) Number: K032293

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Concurrence of CDRH Office of Device Evaluation (ODE)

Prescription Use .........................Per 21 CFR 801.109	OR	Over-The-Counter.........................
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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.