NON-STERILE ORANGE COLORED POWDERED LATEX PATINET EXAMINATION GLOVES WITH & WITHOUT ORANGE/VANILLA SCENTS

• K Number: K030994
• Device Name: NON-STERILE ORANGE COLORED POWDERED LATEX PATINET EXAMINATION GLOVES WITH & WITHOUT ORANGE/VANILLA SCENTS
• Manufacturer: SGMP CO., LTD.
• Date Cleared: 2003-06-12 ( 76 days)
• Product Code: LYY
• Regulation Number: 880.6250
• Type: Traditional
• Panel: General Hospital
• Reference & Predicate Devices: K000671
• Predicate For: N/A

Intended Use

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 ORANGE COLORED POWDERED LATEX PATIENT EXAMINATION GLOVES WITH & WITHOUT ORANGE/VANILLA SCENTS AND WITH A PROTEIN LABELING CLAIM (<200uG/G)

AI/ML Overview

Here's a summary of the acceptance criteria and the study details for the Non-Sterile Orange Colored Powdered Latex Patient Examination Gloves, based on the provided document:

Acceptance Criteria and Device Performance

The device, "Non-Sterile Orange Colored Powdered Latex Patient Examination Gloves with & without Orange/Vanilla Scents and with a Protein Labeling Claim (<200ug/g)", was tested against ASTM D-3578-01aE2 requirements for latex examination gloves and FDA allowable levels for residual protein.

Table of Acceptance Criteria and Reported Device Performance

Feature/Test	Acceptance Criteria (ASTM D-3578-01aE2 & FDA)	Reported Device Performance (SGMP Company, LTD.)
Physical Properties
Unaged Tensile Strength	14.0 MPa (minimum)	22.4 - 25.8 MPa
Aged Tensile Strength	14.0 MPa (minimum)	21.0 - 27.0 MPa
Unaged Ultimate Elongation	700% (minimum)	800 - 830%
Aged Ultimate Elongation	500% (minimum)	820 - 900%
Water Tight Test	2.5% AQL (Acceptable Quality Level)	"The above figures are within the ASTM D-3578-01aE2 requirements" (Number of leaked gloves: 0-2 out of 125 samples per batch/size)
Biocompatibility	(Implicit: Passed standard tests)	"Test indicate that the gloves passed the biocompatibility tests for gloves."
Residual Protein Level	< 200 µg/g (FDA allowable level for protein labeling claim)	Claimed Level: < 200 µg/g; Range: 98–112 µg/g; Mean: 101 µg/g

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Study Details

This document describes a 510(k) premarket notification, which demonstrates substantial equivalence to a legally marketed predicate device rather than a comprehensive de novo study to prove the device meets acceptance criteria from scratch as one might for a novel AI device. The tests performed are standard quality control and performance verification tests for medical gloves.

1. Sample size used for the test set and the data provenance:

   • Physical Properties: For each of the unaged and aged tests, the sample sizes are implicitly shown across four glove sizes (X-Small, Small, Medium, Large) from "LOT # 0226". Specific N for each test per size is not explicitly stated but typically involves multiple samples to derive mean values. The provenance is internal testing by SGMP Company, LTD.
   • Water Tight Test: 125 samples per batch number/size, for both unaged and aged samples across four sizes (X-Small, Small, Medium, Large). The provenance is internal testing by SGMP Company, LTD.
   • Residual Protein Level: A range (98-112 µg/g) and mean (101 µg/g) are reported, suggesting multiple samples were tested. The specific sample size is not stated. The provenance is internal testing by SGMP Company, LTD.
   • All data appears to be retrospective testing of manufactured batches. The country of origin of the data is not explicitly stated but is implicitly SGMP Company, LTD.'s manufacturing location (which is not in the US, but the submission is for US market approval).

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • For physical properties, watertight tests, and residual protein analysis, the "ground truth" (acceptance criteria) is established by ASTM D-3578-01aE2 standards and FDA allowable levels. These are established industry and regulatory benchmarks rather than expert consensus on individual cases. No "experts" in the sense of clinicians or radiologists are typically involved in establishing ground truth for these device performance tests; rather, it relies on standardized testing methodologies and interpretations.

3. Adjudication method for the test set:

   • Not applicable. The tests involve objective measurements against predefined standards (ASTM and FDA regulations), not subjective interpretations requiring adjudication.

4. 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 document is for a medical device (latex examination gloves) and does not involve AI or human readers for diagnostic interpretation.

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

   • Not applicable. This is for a physical medical device, not a software algorithm.

6. The type of ground truth used:

   • The ground truth for these tests is established industry standards (ASTM) and regulatory requirements (FDA allowable levels for protein). These are objective, quantitative criteria.

7. The sample size for the training set:

   • Not applicable. This is a physical device, and these are performance verification tests, not a machine learning model requiring a training set.

8. How the ground truth for the training set was established:

   • Not applicable. (See #7).

Summary

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JUN 1 2 2003

Appendix I, Page 1 (added)

510(k) SUMMARY FOR

K030994

NON-STERILE ORANGE COLORED POWDERED LATEX PATIENT EXAMINATION GLOVES WITH & WITHOUT ORANGE/VANILLA SCENTS AND WITH A PROTEIN LABELING CLAIM (<200ug/g),

Contains 200 megm on less of fotal Waker extrac per greem . profesn

SGMP COMPANY, LTD. Submitted for:

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 Phone: [phone] Fax: [phone] E-Mail: [e-mail]

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

JC

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Appendix I

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

LOT #	TENSILE STRENGTH				ULTIMATE ELONGATION
	UNAGED		AGED		UNAGED		AGED
0226
TESTEDX-SMALL	SGMP	ASTM	SGMP	ASTM	SGMP	ASTM	SGMP	ASTM
	24.1	14.0	27.0	14.0	820	700	900	500
SMALL	24.8	14.0	24.4	14.0	830	700	870	500
MEDIUM	25.8	14.0	24.2	14.0	820	700	890	500
LARGE	22.4	14.0	21.0	14.0	800	700	820	500

3. Water Tight Test Data

BATCHNUMBER	DATETESTED	SAMPLING SIZE	LEAKSTATUS	NUMBERLEAKED
Unaged Smpl0226 XS	10 Feb 03	125	Yes	1
S		125	No	0
M		125	Yes	1
L		125	Yes	1
Aged Smpl0226 XS	18 Feb 03	125	No	0
S		125	Yes	1
M		125	Yes	2
L		125	No	0

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

4. Biocompatibility

BIOCOMPATIBILITY TESTS

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

5. Residual Protein Level

TESTS	FDA ALLOWABLE LEVEL	CLAIMED LEVEL
ASTM D 5712-99	-	< 200 µg/gRange: 98–112 µg/gMean: 101 µg/g

Revised 5-27-03

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or other bird in flight, rendered in a stylized, minimalist design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 2 2003

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

Re: K030994

Trade/Device Name: Non-Sterile Orange Colored Powdered Latex Examination Gloves with & without Orange/Vanilla Scents and with a Protein Labeling Claim. Contains 200 Micrograms or Less of Total Water Extractable Protein Per Gram Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: May 27, 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 (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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Patricio Cussenhoffer

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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PAGE 02/03

INDICATIONS FOR USE

APPLICANT:

SGMP COMPANY, LTD.

1030994

510(k) NUMBER:

DEVICE NAME:

NON-STERILE ORANGE COLORED POWDERED LATEX PATIENT EXAMINATION GLOVES WITH & WITHOUT ORANGE/VANILLA SCENTS AND WITH A PROTEIN LABELING CLAIM (<200uG/G) Umfars

over sytractable profess per gram Wall : q to fal OR less 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)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use_

(Optional Format 1-2-96)

Chiu S. Lin

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

510(k) Number

Revised 06-04-0

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.