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.

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

Here's a breakdown of the acceptance criteria and study information for the SGMP Company Ltd. latex examination gloves, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test/Parameter	Acceptance Criteria (ASTM D3578-01aE2 or FDA Internal)	Reported Device Performance (SGMP)
Dimensions	X-Small (width)	70 mm +/- 10 mm	70 - 75 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	0.08 mm min
	Thickness - Palm	0.08 mm min	0.08 mm min
Physical Properties (Before Aging)	Tensile Strength	14.0 Mpa	22.0 - 30.2 Mpa (depending on size)
	Ultimate Elongation	700 %	800 - 900 % (depending on size)
Physical Properties (After Aging)	Tensile Strength	14.0 Mpa	24.6 - 28.3 Mpa (depending on size)
	Ultimate Elongation	500 %	800 - 830 % (depending on size)
Water Tight Test (Leakage)	Acceptable Quality Level (AQL)	2.5% AQL (implied from FDA pinhole requirements)	Within 2.5% AQL (1-4 leaks out of 500 total tested)
Biocompatibility	General Biocompatibility	Passed tests for examination gloves (specifics not listed)	Passed the tests for examination gloves
Residual Powder Content	Residual Powder Content	2 mg/glove max (FDA internal requirement)	Range: 0.5-0.9 mg/glove, Mean: 0.7 mg/glove
	Presence of Cornstarch	Negative	Negative
Residual Protein Level	Latex Protein Level (ASTM D 5712-99)	< 50 µg/g (FDA allowable level)	< 50 µg/g (claimed level)

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

Sample Size (Water Tight Test): 125 pieces for each of the four sizes (X-Small, Small, Medium, Large) for both un-aged and aged gloves. This totals 1000 gloves tested for the water tight test (125 * 4 * 2).
Sample Size (Physical Properties): Not explicitly stated, but measurements are provided for each of the four sizes both before and after aging, suggesting multiple samples per size.
Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. It is implied to be data collected specifically for the 510(k) submission, likely prospective, provided by the manufacturer (SGMP Company Ltd.).

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

This information is not applicable to this device. The tests performed are objective, quantitative measurements of physical and chemical properties of the gloves, not assessments requiring expert interpretation (like medical images). The "ground truth" is defined by established international and FDA standards (e.g., ASTM D3578-01aE2, FDA internal requirements).

4. Adjudication Method for the Test Set

This information is not applicable as the tests are objective measurements, not subjective evaluations that require adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices involving human interpretation (e.g., radiologists reading images) and comparing performance with and without AI assistance. This device is a medical glove, and its performance is assessed through laboratory-based physical and chemical tests, not human reading of cases.

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

Not applicable. This device is a physical product (medical glove), not an algorithm or software. Its performance is inherent in its physical properties and chemical composition.

7. The Type of Ground Truth Used

The ground truth used for these tests is based on established industry standards and regulatory requirements. These include:
- ASTM D3578-01aE2 Standard Specification for Latex Examination Gloves for Medical Application
- ASTM D 6124-01 for Residual Powder Content
- ASTM D 5712-99 for Residual Protein Level
- FDA internal requirements (e.g., for residual powder content, pinhole AQL).
- Biocompatibility tests (details not provided in the summary but indicated as "per attached in APPENDIX L").

8. The Sample Size for the Training Set

Not applicable. This device is a physical product, not an AI/ML algorithm that requires a training set. The "training" here refers to the manufacturing process adhering to quality control.

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

Not applicable. As stated above, there is no "training set" in the context of an AI/ML device. The ground truth for the manufacturing process is established by adherence to Good Manufacturing Practices (GMP) and the quality control standards outlined in section 7.

Summary

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K032294

APPENDIX M

510(k) SUMMARY

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

Submitted For: SGMP COMPANY LTD.

Submitted By: TUCKER & ASSOCIATES 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: Tuckerjanía aol.com E-Mail:

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 ORANGE LATEX EXAMGLOVES WITH/WITHOUT ORANGE/VANILLASCENTING 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:

1. Dimension

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 -FingerPalm	0.08mm min0.08mm min	0.08 mm min0.08 mm min

1. Physical Properties (ASTM-D3578-01aE2 Standard Specification for Latex Exam Gloves)
  on Lot# 0324

	TENSILE STRENGTH		ULTIMATE ELONGATION
	ASTM-D3578-01aE2	SGMP	ASTM-D3578-01aE2	SGMP
Before AgingX-SmallSmallMediumLarge	Mpa14.0	Mpa22.028.130.224.3	%700	%800850900810
After AgingX-SmallSmallMediumLarge	14.0	25.428.326.224.6	500	800830830800

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3. Water Tight Test

BATCH #	SIZE	SAMPLE SIZE	LEAK STATUS	NUMBER LEAKED
UN-AGED
0324	X-Small	125	Yes	1
0324	Small	125	No	0
0324	Medium	125	Yes	1
0324	Large	125	No	0
AGED
0324	X-Small	125	Yes	1
0324	Small	125	No	0
0324	Medium	125	Yes	1
0324	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.

4. Biocompatibility

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: 0.5-0.9mg/gloveMean : 0.7 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 Orange latex examination glove with Orange/Vanilla Scenting

1. meets/exceeds ASTM- D3578-01aE2 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 labeling claim level at <50 µg/g.

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Image /page/4/Picture/1 description: The image is a black and white circular seal. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a stylized image of an eagle with three curved lines representing its wings.

Public Health Service

AUG 2 8 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K032294

Trade/Device Name: Non-Sterile Powder-Free Orange Latax Examination Glove with or without Orange/Vanilla 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 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 (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 Runner

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

K032294 510K NUMBER :

Device Name : Non-sterile Powder Free Orange Latex Examination Gloves with or without Orange/Vanilla Scenting PLUSS A PROTENAL grans on Ress of for fas water Contains of the 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.

Qim S. Lim

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

510(k) Number: K032294

Concurrence of CDRH Office of Device Evaluation (ODE)

Prescription Use ......... Per 21 CFR 801.109

Over-The-Counter .......................

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.