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 patient and examiner.

Device Description

NON-STERILE GREEN COLORED POWDERED LATEX PATIENT EXAMINATION GLOVES WITH & WITHOUT SOUR APPLE/PEPPERMINT SCENTS AND WITH A PROTEIN LABELING CLAIM (<200ug/g) Contains 200 migm or less of for at Water Extractable

AI/ML Overview

The provided text describes the acceptance criteria and performance data for "NON-STERILE GREEN COLORED POWDERED LATEX PATIENT EXAMINATION GLOVES WITH & WITHOUT SOUR APPLE/PEPPERMINT SCENTS AND WITH A PROTEIN LABELING CLAIM (<200ug/g)".

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standard / Limit)	Reported Device Performance (SGMP ASTM)	Notes
Tensile Strength (Unaged)	≥ 14.0	X-SMALL: 22.6, SMALL: 21.9, MEDIUM: 21.7, LARGE: 21.3
Tensile Strength (Aged)	≥ 14.0	X-SMALL: 20.8, SMALL: 22.5, MEDIUM: 22.8, LARGE: 20.7
Ultimate Elongation (Unaged)	≥ 700	X-SMALL: 820, SMALL: 920, MEDIUM: 970, LARGE: 950
Ultimate Elongation (Aged)	≥ 500	X-SMALL: 950, SMALL: 920, MEDIUM: 880, LARGE: 896
Water Tight Test (AQL)	2.5%	Unaged (XS, S, M, L): 0, 1, 2, 1 leaks respectively. Aged (XS, S, M, L): 0, 1, 2, 1 leaks respectively. All figures are within 2.5% AQL.
Biocompatibility	Passed tests	The gloves passed biocompatibility tests.
Residual Protein Level	< 200 µg/g (FDA allowable level)	Claimed Level: < 200 µg/g; Range: 91 – 123 µg/g; Mean: 112 µg/g (based on ASTM D 5712-99)

2. Sample Size for the Test Set and Data Provenance

Tensile Strength & Ultimate Elongation: The data is presented by glove size (X-SMALL, SMALL, MEDIUM, LARGE) for one "LOT # 0238". The specific number of gloves tested for each measurement (tensile strength and elongation) is not explicitly stated.
Water Tight Test: "SAMPLING SIZE" is listed as 125 gloves for each size (XS, S, M, L) for both unaged and aged samples, totaling 1000 gloves (4 sizes * 2 conditions * 125 gloves/sample).
Residual Protein Level: No specific sample size is mentioned for the protein level testing, but a range and mean are provided.
Data Provenance: The document does not specify the country of origin for the data. The data appears to be from internal testing by SGMP (SGMP ASTM) and is retrospective, conducted to support the 510(k) submission.

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

Not applicable. This device is a physical product (gloves), and performance is determined by objective physical and chemical testing against established standards (ASTM-D3578-01aE2, ASTM D 5712-99) and FDA allowable levels. Expert consensus for ground truth is not relevant in this context.

4. Adjudication Method for the Test Set

Not applicable. Performance is based on direct measurement and comparison to predefined ASTM standards and AQL limits for physical properties and chemical composition. There is no human judgment involved that would require an adjudication method.

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 that involve human interpretation of medical images or data. The device in question is a patient examination glove.

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

Not applicable. This device is a physical product (gloves), not an algorithm or software. Its performance is assessed through laboratory testing.

7. The Type of Ground Truth Used

The ground truth used for this device's performance evaluation is based on:

ASTM Consensus Standards: Specifically, ASTM-D3578-01aE2 for Physical Properties (Tensile Strength, Ultimate Elongation, Water Tight Test) and ASTM D 5712-99 for Residual Protein Level. These are widely accepted industry standards for latex examination gloves, established through a consensus process by experts in the field.
Regulatory Limits: The FDA's allowable level for total extractable protein (< 200 µg/g) serves as a regulatory ground truth for this claim.

8. The Sample Size for the Training Set

Not applicable. This device is a physical product and its performance validation relies on direct testing against established standards, not on machine learning or AI models that require training sets.

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

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

Summary

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JUN 1 2 2003

Appendix I, Page 1 (added)

510(k) SUMMARY FOR

K030993

NON-STERILE GREEN COLORED POWDERED LATEX PATIENT EXAMINATION GLOVES WITH & WITHOUT SOUR APPLE/PEPPERMINT SCENTS AND WITH A PROTEIN LABELING CLAIM (<200ug/g)

Contains 200 migm or less of for at Water Extractable

Submitted for: SGMP COMPANY, LTD.

Submitted by:	TUCKER & ASSOCIATESOfficial Correspondent for SGMP COMPANY, LTD.JANNA P. TUCKER, President – CEO198 Avenue de la D'emeraldSparks, NV 89434-9550Phone: 775-342-2612Fax: 775-342-2613E-Mail: Tuckerian@aol.com
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This device is substantially equivalent to K000671, which is another of SGMP's Colored, and/or scented powdered latex gloves with protein labeling (<200ug/g).

Revised 06-04-03

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LOT #	TENSILE STRENGTH		ULTIMATE ELONGATION
0238	UNAGED	AGED	UNAGED	AGED
TESTED	SGMP ASTM	SGMP ASTM	SGMP ASTM	SGMP ASTM
X-SMALL	22.6 14.0	20.8 14.0	820 700	950 500
SMALL	21.9 14.0	22.5 14.0	920 700	920 500
MEDIUM	21.7 14.0	22.8 14.0	970 700	880 500
LARGE	21.3 14.0	20.7 14.0	950 700	896 500

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

3. Water Tight Test Data

BATCHNUMBER	DATETESTED	SAMPLING SIZE	LEAKSTATUS	NUMBERLEAKED
Unaged Smpl0238 XSSML	10 Feb 03	125125125125	NoYesYesYes	0121
Aged Smpl0238 XSSML	18 Feb 03	125125125125	NoYesYesYes	0121

The above figures are within the ASTM D-3578-01aE2 requirements for latex exam gloves of 2.5% AQL.

4. Biocompatibility

BIOCOMPATIBILITY TESTS

Test results indicate that the gloves the passed biocompatibility tests for gloves.

5. Residual Protein Level

TESTS	FDA ALLOWABLE LEVEL	CLAIMED LEVEL
ASTM D 5712-99		< 200 µg/gRange: 91 – 123 µg/gMean: 112 µg/g

Revised 5-28.03

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Public Health Service

JUN 1 2 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K030993

Trade/Device Name: Non-Sterile Powdered Green Colored Powdered Latex Patient with or without Sour Apple, Peppermint Scents, Contains 200 Micrograms or Less of Total Extractable Protein Per Gram Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: May 28, 2003 Received: May 29, 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 (OS) 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.

Pattico Cusentiffoce

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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INDICATIONS FOR USE

APPLICANT:

SGMP COMPANY, LTD.

1030993

510(k) NUMBER:

DEVICE NAME:

NON-STERILE GREEN COLORED POWDERED LATEX PATIENT EXAMINATION GLOVES WITH & WITHOUT SOUR APPLE/PEPPERMINT SCENTS A WITH A PROTEIN LABELI (<200uG/G) Contains 200 mg setractable profein per

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 patient and examiner.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Olin S. Lim
(Division Sign-Off)

ion of Anesthesiology, General Hospital, ntrol, Dental Devices

Prescription Use (Per 21 CFR 801.109)

510(k) Number: K030993

OR Over-The-Counter Use

(Optional Format 1-2-96)

Revised 06-04-03

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.